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Siemens Healthcare Diagnostics, Inc.

467 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for th recall (Z-1647-2014)Siemens Healthcare Diagnostics, Inc.2014-05-21
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SM recall (Z-1564-2014)Siemens Healthcare Diagnostics, Inc2014-05-07
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946. recall (Z-1545-2014)Siemens Healthcare Diagnostics Inc2014-05-04
Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagno recall (Z-1076-2014)Siemens Healthcare Diagnostics, Inc.2014-02-24
Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA recall (Z-0940-2014)Siemens Healthcare Diagnostics, Inc.2014-02-09
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diag recall (Z-0929-2014)Siemens Healthcare Diagnostics, Inc2014-02-04
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diag recall (Z-0930-2014)Siemens Healthcare Diagnostics, Inc2014-02-04
User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 Sy recall (Z-0851-2014)Siemens Healthcare Diagnostics, Inc.2014-01-28
Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink syst recall (Z-0823-2014)Siemens Healthcare Diagnostics, Inc.2014-01-24
Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the qu recall (Z-0818-2014)Siemens Healthcare Diagnostics, Inc.2014-01-23
Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyze recall (Z-0800-2014)Siemens Healthcare Diagnostics, Inc.2014-01-21
HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimensio recall (Z-0625-2014)Siemens Healthcare Diagnostics, Inc.2014-01-03
HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimensi recall (Z-0626-2014)Siemens Healthcare Diagnostics, Inc.2014-01-03
Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: recall (Z-0561-2014)Siemens Healthcare Diagnostics, Inc.2013-12-24
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro recall (Z-0541-2014)Siemens Healthcare Diagnostics, Inc.2013-12-19
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnos recall (Z-0517-2014)Siemens Healthcare Diagnostics, Inc.2013-12-16
syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data fro recall (Z-0433-2014)Siemens Healthcare Diagnostics, Inc.2013-12-03
Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to sys recall (Z-0430-2014)Siemens Healthcare Diagnostics, Inc.2013-12-02
Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay recall (Z-0181-2014)Siemens Healthcare Diagnostics, Inc.2013-11-07
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro di recall (Z-0173-2014)Siemens Healthcare Diagnostics, Inc2013-11-06
Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended recall (Z-0102-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intende recall (Z-0103-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The recall (Z-0104-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0105-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0106-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0107-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The recall (Z-0108-2014)Siemens Healthcare Diagnostics Inc2013-10-29
Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge recall (Z-0017-2014)Siemens Healthcare Diagnostics, Inc.2013-10-17
Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Pa recall (Z-2119-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & recall (Z-2120-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies pl recall (Z-2121-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Pa recall (Z-2122-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Pa recall (Z-2123-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergie recall (Z-2124-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Sy recall (Z-2125-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroSc recall (Z-2126-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus recall (Z-2127-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plu recall (Z-2128-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plu recall (Z-2129-2013)Siemens Healthcare Diagnostics, Inc.2013-09-11
ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use i recall (Z-2169-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in recall (Z-2170-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic u recall (Z-2171-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic recall (Z-2172-2013)Siemens Healthcare Diagnostics, Inc2013-09-10
Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with soft recall (Z-2088-2013)Siemens Healthcare Diagnostics, Inc.2013-08-26
ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10 recall (Z-1970-2013)Siemens Healthcare Diagnostics, Inc2013-08-14
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product recall (Z-1924-2013)Siemens Healthcare Diagnostics, Inc.2013-08-07
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase M recall (Z-1925-2013)Siemens Healthcare Diagnostics, Inc.2013-08-07
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 recall (Z-1881-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human recall (Z-1882-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitativ recall (Z-1883-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively recall (Z-1884-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KT recall (Z-1885-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T) recall (Z-1886-2013)Siemens Healthcare Diagnostics, Inc2013-08-06
Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 1048 recall (Z-1525-2013)Siemens Healthcare Diagnostics, Inc.2013-06-08
ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in recall (Z-1512-2013)Siemens Healthcare Diagnostics, Inc2013-06-06
ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitr recall (Z-1513-2013)Siemens Healthcare Diagnostics, Inc2013-06-06
ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrati recall (Z-1514-2013)Siemens Healthcare Diagnostics, Inc2013-06-06
ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use i recall (Z-1515-2013)Siemens Healthcare Diagnostics, Inc2013-06-06
Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MI recall (Z-1272-2013)Siemens Healthcare Diagnostics, Inc.2013-05-08
Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vit recall (Z-1151-2013)Siemens Healthcare Diagnostics, Inc.2013-04-18
ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quan recall (Z-1119-2013)Siemens Healthcare Diagnostics, Inc2013-04-15
ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quant recall (Z-1120-2013)Siemens Healthcare Diagnostics, Inc2013-04-15
ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quant recall (Z-1121-2013)Siemens Healthcare Diagnostics, Inc2013-04-15
ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quant recall (Z-1122-2013)Siemens Healthcare Diagnostics, Inc2013-04-15
Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated recall (Z-1073-2013)Siemens Healthcare Diagnostics, Inc.2013-04-09
Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PH recall (Z-1049-2013)Siemens Healthcare Diagnostics, Inc.2013-04-02
Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a recall (Z-1046-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measu recall (Z-1047-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a recall (Z-1048-2013)Siemens Healthcare Diagnostics, Inc.2013-04-01
Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitr recall (Z-0988-2013)Siemens Healthcare Diagnostics, Inc.2013-03-25
Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used recall (Z-0957-2013)Siemens Healthcare Diagnostics, Inc.2013-03-15
Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic recall (Z-0933-2013)Siemens Healthcare Diagnostics, Inc.2013-03-11
Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IR recall (Z-0745-2013)Siemens Healthcare Diagnostics, Inc.2013-01-29
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019 recall (Z-0664-2013)Siemens Healthcare Diagnostics, Inc.2013-01-10
Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Seru recall (Z-0665-2013)Siemens Healthcare Diagnostics, Inc.2013-01-10
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number: recall (Z-0635-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Nu recall (Z-0636-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control S recall (Z-0637-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OU recall (Z-0638-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix Positiv recall (Z-0639-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positiv recall (Z-0640-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive and recall (Z-0641-2013)Siemens Healthcare Diagnostics Inc2013-01-04
Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 0281613 recall (Z-0506-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref K recall (Z-0507-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use T recall (Z-0508-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS recall (Z-0509-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08861968 Inten recall (Z-0510-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367974 Ref Kit recall (Z-0511-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test 03009619 recall (Z-0512-2013)Siemens Healthcare Diagnostics, Inc2012-12-11
Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro d recall (Z-0452-2013)Siemens Healthcare Diagnostics, Inc.2012-12-03
Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The recall (Z-0408-2013)Siemens Healthcare Diagnostics, Inc.2012-11-20
Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diag recall (Z-0253-2013)Siemens Healthcare Diagnostics, Inc.2012-11-06
Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); RE recall (Z-0162-2013)Siemens Healthcare Diagnostics, Inc2012-10-28
Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019 recall (Z-0030-2013)Siemens Healthcare Diagnostics, Inc.2012-10-10
ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 recall (Z-2409-2012)Siemens Healthcare Diagnostics, Inc2012-09-19
ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or recall (Z-2410-2012)Siemens Healthcare Diagnostics, Inc2012-09-19
Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur recall (Z-2313-2012)Siemens Healthcare Diagnostics, Inc2012-09-06
syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is c recall (Z-2305-2012)Siemens Healthcare Diagnostics, Inc.2012-08-31
Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 50 recall (Z-2283-2012)Siemens Healthcare Diagnostics, Inc.2012-08-28
EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vist recall (Z-2242-2012)Siemens Healthcare Diagnostics, Inc.2012-08-22
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