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Siemens Healthcare Diagnostics, Inc.

465 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for cal recall (Z-0615-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibra recall (Z-0616-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibra recall (Z-0617-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic recall (Z-0618-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conj recall (Z-0619-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Managemen recall (Z-0458-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Manag recall (Z-0459-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Manage recall (Z-0460-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Manage recall (Z-0461-2016)Siemens Healthcare Diagnostics Inc.2015-12-22
Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 104 recall (Z-0468-2016)Siemens Healthcare Diagnostics, Inc.2015-12-22
Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. F recall (Z-0339-2016)Siemens Healthcare Diagnostics, Inc.2015-11-25
ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, recall (Z-0340-2016)Siemens Healthcare Diagnostics, Inc.2015-11-25
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Pro recall (Z-2813-2015)Siemens Healthcare Diagnostics Inc2015-09-24
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Pro recall (Z-2814-2015)Siemens Healthcare Diagnostics Inc2015-09-24
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Pro recall (Z-2815-2015)Siemens Healthcare Diagnostics Inc2015-09-24
Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Pro recall (Z-2816-2015)Siemens Healthcare Diagnostics Inc2015-09-24
Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on recall (Z-2741-2015)Siemens Healthcare Diagnostics, Inc.2015-09-05
ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare th recall (Z-2739-2015)Siemens Healthcare Diagnostics, Inc2015-09-04
RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 1069 recall (Z-2479-2015)Siemens Healthcare Diagnostics Inc2015-08-28
Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC recall (Z-2450-2015)Siemens Healthcare Diagnostics, Inc.2015-08-22
ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative de recall (Z-2416-2015)Siemens Healthcare Diagnostics, Inc.2015-08-19
ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Produc recall (Z-2207-2015)Siemens Healthcare Diagnostics, Inc2015-07-23
Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Inte recall (Z-2054-2015)Siemens Healthcare Diagnostics, Inc.2015-07-09
CentraLink" Data Management System; software is a network solution provider and multi-syst recall (Z-1957-2015)Siemens Healthcare Diagnostics, Inc.2015-07-02
The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gase recall (Z-1961-2015)Siemens Healthcare Diagnostics, Inc2015-07-02
The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gase recall (Z-1962-2015)Siemens Healthcare Diagnostics, Inc2015-07-02
EasyLink Data Management System; a clinical data management system that assists medical la recall (Z-1942-2015)Siemens Healthcare Diagnostics, Inc.2015-06-30
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro recall (Z-2149-2014)Siemens Healthcare Diagnostics, Inc2015-06-26
SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro recall (Z-2150-2014)Siemens Healthcare Diagnostics, Inc2015-06-26
IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Sie recall (Z-1843-2015)Siemens Healthcare Diagnostics, Inc.2015-06-25
Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent f recall (Z-1713-2015)Siemens Healthcare Diagnostics, Inc.2015-06-05
Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro di recall (Z-1708-2015)Siemens Healthcare Diagnostics, Inc.2015-06-04
Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma acti recall (Z-1703-2015)Siemens Healthcare Diagnostics, Inc.2015-06-02
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Bi recall (Z-1629-2015)Siemens Healthcare Diagnostics, Inc.2015-05-19
Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL M recall (Z-1615-2015)Siemens Healthcare Diagnostics, Inc.2015-05-14
ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894. recall (Z-1457-2015)Siemens Healthcare Diagnostics, Inc.2015-04-20
QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension cl recall (Z-1398-2015)Siemens Healthcare Diagnostics, Inc.2015-04-07
ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siem recall (Z-1399-2015)Siemens Healthcare Diagnostics, Inc.2015-04-07
ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration recall (Z-1321-2015)Siemens Healthcare Diagnostics, Inc.2015-03-25
N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in huma recall (Z-1289-2015)Siemens Healthcare Diagnostics, Inc.2015-03-17
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, recall (Z-1252-2015)Siemens Healthcare Diagnostics Inc2015-03-06
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, recall (Z-1253-2015)Siemens Healthcare Diagnostics Inc2015-03-06
RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab recall (Z-1254-2015)Siemens Healthcare Diagnostics Inc2015-03-06
RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab recall (Z-1255-2015)Siemens Healthcare Diagnostics Inc2015-03-06
Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collec recall (Z-1256-2015)Siemens Healthcare Diagnostics Inc2015-03-06
Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood col recall (Z-1257-2015)Siemens Healthcare Diagnostics Inc2015-03-06
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood colle recall (Z-1258-2015)Siemens Healthcare Diagnostics Inc2015-03-06
ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 023 recall (Z-1229-2015)Siemens Healthcare Diagnostics, Inc2015-03-02
ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01 recall (Z-1230-2015)Siemens Healthcare Diagnostics, Inc2015-03-02
ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: recall (Z-1231-2015)Siemens Healthcare Diagnostics, Inc2015-03-02
ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific c recall (Z-0987-2015)Siemens Healthcare Diagnostics, Inc.2015-01-15
Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnos recall (Z-0946-2015)Siemens Healthcare Diagnostics, Inc.2015-01-08
ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagno recall (Z-0859-2015)Siemens Healthcare Diagnostics, Inc.2014-12-23
ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laborato recall (Z-0860-2015)Siemens Healthcare Diagnostics, Inc.2014-12-23
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: recall (Z-0838-2015)Siemens Healthcare Diagnostics, Inc.2014-12-20
Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack R recall (Z-0164-2015)Siemens Healthcare Diagnostics, Inc2014-12-16
Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin recall (Z-0801-2015)Siemens Healthcare Diagnostics, Inc.2014-12-12
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagen recall (Z-0420-2015)Siemens Healthcare Diagnostics, Inc.2014-11-21
ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B recall (Z-0229-2015)Siemens Healthcare Diagnostics, Inc2014-11-19
ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro di recall (Z-0214-2015)Siemens Healthcare Diagnostics, Inc2014-11-14
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 recall (Z-0212-2015)Siemens Healthcare Diagnostics, Inc.2014-11-13
Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are des recall (Z-0170-2015)Siemens Healthcare Diagnostics, Inc.2014-11-07
Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 104 recall (Z-0171-2015)Siemens Healthcare Diagnostics, Inc.2014-11-07
siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension cl recall (Z-0148-2015)Siemens Healthcare Diagnostics, Inc.2014-10-29
Dimension Vista HbA1c recall (Z-0127-2015)Siemens Healthcare Diagnostics, Inc.2014-10-24
ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVI recall (Z-0128-2015)Siemens Healthcare Diagnostics, Inc2014-10-24
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur recall (Z-0129-2015)Siemens Healthcare Diagnostics, Inc2014-10-24
ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur recall (Z-0130-2015)Siemens Healthcare Diagnostics, Inc2014-10-24
Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catal recall (Z-0102-2015)Siemens Healthcare Diagnostics, Inc2014-10-21
ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 0 recall (Z-0103-2015)Siemens Healthcare Diagnostics, Inc2014-10-21
External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems recall (Z-0081-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
External power supply adaptors that accompany Clinitek Status Connect System The Clinitek recall (Z-0082-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare recall (Z-0083-2015)Siemens Healthcare Diagnostics, Inc2014-10-17
Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product fo recall (Z-0024-2015)Siemens Healthcare Diagnostics, Inc.2014-10-06
Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic p recall (Z-2720-2014)Siemens Healthcare Diagnostics, Inc.2014-09-30
Siemens CentraLink Data Management System, software version 14. The CentraLink system soft recall (Z-2665-2014)Siemens Healthcare Diagnostics, Inc.2014-09-18
Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444 recall (Z-2561-2014)Siemens Healthcare Diagnostics, Inc.2014-09-01
Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to recall (Z-2553-2014)Siemens Healthcare Diagnostics, Inc.2014-08-26
Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used recall (Z-2238-2014)Siemens Healthcare Diagnostics, Inc.2014-08-15
Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human recall (Z-2133-2014)Siemens Healthcare Diagnostics, Inc.2014-07-30
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge recall (Z-2079-2014)Siemens Healthcare Diagnostics Inc2014-07-18
Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the recall (Z-2071-2014)Siemens Healthcare Diagnostics Inc2014-07-17
Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcar recall (Z-2058-2014)Siemens Healthcare Diagnostics Inc.2014-07-15
ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, an recall (Z-1960-2014)Siemens Healthcare Diagnostics, Inc2014-07-02
MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access doo recall (Z-1990-2014)Siemens Healthcare Diagnostics, Inc.2014-07-02
ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 a recall (Z-1991-2014)Siemens Healthcare Diagnostics, Inc2014-07-02
syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573. recall (Z-1944-2014)Siemens Healthcare Diagnostics, Inc.2014-06-30
Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrato recall (Z-1926-2014)Siemens Healthcare Diagnostics, Inc.2014-06-26
Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reage recall (Z-1927-2014)Siemens Healthcare Diagnostics, Inc2014-06-26
Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate recall (Z-1867-2014)Siemens Healthcare Diagnostics, Inc.2014-06-25
Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: recall (Z-1733-2014)Siemens Healthcare Diagnostics, Inc.2014-06-09
ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Ma recall (Z-1653-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens recall (Z-1654-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Num recall (Z-1655-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for th recall (Z-1656-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for th recall (Z-1657-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for recall (Z-1658-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883. recall (Z-1659-2014)Siemens Healthcare Diagnostics, Inc2014-05-23
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
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