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Siemens Healthcare Diagnostics, Inc.

465 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Nu recall (Z-0718-2023)Siemens Healthcare Diagnostics, Inc.2022-12-15
IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMU recall (Z-0355-2023)Siemens Healthcare Diagnostics, Inc.2022-12-02
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assa recall (Z-0104-2023)Siemens Healthcare Diagnostics, Inc.2022-10-20
Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay recall (Z-0105-2023)Siemens Healthcare Diagnostics, Inc.2022-10-20
Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Si recall (Z-0089-2023)Siemens Healthcare Diagnostics, Inc.2022-10-14
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens M recall (Z-0093-2023)SIEMENS HEALTHCARE DIAGNOSTICS INC2022-10-14
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens recall (Z-0094-2023)SIEMENS HEALTHCARE DIAGNOSTICS INC2022-10-14
IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Mate recall (Z-1820-2022)Siemens Healthcare Diagnostics, Inc.2022-09-27
Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog recall (Z-1816-2022)Siemens Healthcare Diagnostics, Inc.2022-09-26
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitat recall (Z-1648-2022)Siemens Healthcare Diagnostics, Inc.2022-08-29
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin recall (Z-1340-2022)Siemens Healthcare Diagnostics, Inc.2022-07-06
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin- recall (Z-1341-2022)Siemens Healthcare Diagnostics, Inc.2022-07-06
Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2 recall (Z-1274-2021)Siemens Healthcare Diagnostics, Inc2021-03-18
Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagn recall (Z-0134-2021)Siemens Healthcare Diagnostics, Inc.2020-10-20
ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitativ recall (Z-0101-2021)Siemens Healthcare Diagnostics, Inc.2020-10-13
Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative me recall (Z-0102-2021)Siemens Healthcare Diagnostics, Inc.2020-10-13
Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960 recall (Z-2404-2020)Siemens Healthcare Diagnostics, Inc.2020-06-19
Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026 recall (Z-2405-2020)Siemens Healthcare Diagnostics, Inc.2020-06-19
ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number recall (Z-2280-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 0063 recall (Z-2281-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630 recall (Z-2282-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 006304145 recall (Z-2283-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 0084276803051 recall (Z-2284-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 0084276 recall (Z-2285-2020)Siemens Healthcare Diagnostics, Inc.2020-06-05
Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143 recall (Z-1421-2020)Siemens Healthcare Diagnostics, Inc.2020-03-02
Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 006 recall (Z-1599-2020)Siemens Healthcare Diagnostics, Inc.2020-02-27
IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: recall (Z-1513-2020)Siemens Healthcare Diagnostics, Inc.2020-02-24
IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 recall (Z-1514-2020)Siemens Healthcare Diagnostics, Inc.2020-02-24
ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI recall (Z-1363-2020)Siemens Healthcare Diagnostics, Inc.2020-01-30
ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869 recall (Z-1230-2020)Siemens Healthcare Diagnostics, Inc.2020-01-24
Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533 recall (Z-1231-2020)Siemens Healthcare Diagnostics, Inc.2020-01-24
Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520 recall (Z-1232-2020)Siemens Healthcare Diagnostics, Inc.2020-01-24
Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444 recall (Z-1233-2020)Siemens Healthcare Diagnostics, Inc.2020-01-24
Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SM recall (Z-0829-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells recall (Z-0830-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red b recall (Z-0831-2020)Siemens Healthcare Diagnostics, Inc2020-01-21
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128 recall (Z-2289-2019)Siemens Healthcare Diagnostics, Inc.2019-08-17
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN N recall (Z-2290-2019)Siemens Healthcare Diagnostics, Inc.2019-08-17
Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge recall (Z-1668-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Free Thyroxine (FT4L) Flex reagent cartridge recall (Z-1669-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Sirolimus (SIRO) Flex reagent cartridge recall (Z-1670-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge recall (Z-1671-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge recall (Z-1672-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge recall (Z-1673-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit recall (Z-1674-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi Anti HBc recall (Z-1675-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi Folic Acid recall (Z-1676-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 BR-MA (CA15-3) recall (Z-1677-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 CEA recall (Z-1678-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi CEA recall (Z-1679-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 Gastrin recall (Z-1680-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi Gastrin recall (Z-1681-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 OM-MA (CA125) recall (Z-1682-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125) recall (Z-1683-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 TG recall (Z-1684-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi TG recall (Z-1685-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE /IMMULITE 1000 Vitamin B12 recall (Z-1686-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
ADVIA Centaur Cyclosporine recall (Z-1687-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
ADVIA Centaur DHEA-SO4 recall (Z-1688-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
ADVIA Centaur Folate (FOL) recall (Z-1689-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
ADVIA Centaur HBc IgM recall (Z-1690-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3) recall (Z-1691-2018)Siemens Healthcare Diagnostics, Inc.2018-05-04
Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic p recall (Z-1184-2018)Siemens Healthcare Diagnostics, Inc.2018-03-26
Dimension Troponin 1 (TNI) Flex reagent cartridge recall (Z-2606-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Dimension Vista Digoxin (DIGXN) Flex reagent cartridge recall (Z-2607-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Dimension Vista Estradiol (E2) Flex reagent cartridge recall (Z-2608-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Dimension Vista Ferritin (FERR) Flex reagent cartridge recall (Z-2609-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Dimension Vista Prolactin (PRL) Flex reagent cartridge recall (Z-2610-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge recall (Z-2611-2017)Siemens Healthcare Diagnostics, Inc.2017-05-05
ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618 recall (Z-2085-2017)Siemens Healthcare Diagnostics, Inc2017-04-19
ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in recall (Z-2086-2017)Siemens Healthcare Diagnostics, Inc2017-04-19
SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 200 recall (Z-2166-2017)Siemens Healthcare Diagnostics, Inc.2017-04-19
Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System recall (Z-1703-2017)Siemens Healthcare Diagnostics, Inc.2017-03-19
ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included recall (Z-1712-2017)Siemens Healthcare Diagnostics, Inc.2017-03-15
ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVI recall (Z-1537-2017)Siemens Healthcare Diagnostics, Inc.2017-02-23
Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Numb recall (Z-0039-2017)Siemens Healthcare Diagnostics, Inc.2016-10-04
Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161 recall (Z-2912-2016)Siemens Healthcare Diagnostics Inc2016-09-30
Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313 recall (Z-2913-2016)Siemens Healthcare Diagnostics Inc2016-09-30
IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like grow recall (Z-2841-2016)Siemens Healthcare Diagnostics, Inc.2016-09-16
Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A T recall (Z-2601-2016)Siemens Healthcare Diagnostics Inc2016-08-19
Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immu recall (Z-2298-2016)Siemens Healthcare Diagnostics, Inc.2016-07-28
ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic recall (Z-2299-2016)Siemens Healthcare Diagnostics, Inc.2016-07-28
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3 recall (Z-1885-2016)Siemens Healthcare Diagnostics Inc.2016-06-01
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V. recall (Z-1886-2016)Siemens Healthcare Diagnostics Inc.2016-06-01
ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLAS recall (Z-1615-2016)Siemens Healthcare Diagnostics, Inc.2016-05-06
Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the recall (Z-1618-2016)Siemens Healthcare Diagnostics, Inc.2016-05-06
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 0463445 recall (Z-1077-2016)Siemens Healthcare Diagnostics, Inc2016-03-08
Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 0463476 recall (Z-1078-2016)Siemens Healthcare Diagnostics, Inc2016-03-08
Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Numb recall (Z-1079-2016)Siemens Healthcare Diagnostics, Inc2016-03-08
Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalo recall (Z-1030-2016)Siemens Healthcare Diagnostics, Inc.2016-03-01
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulat recall (Z-0824-2016)Siemens Healthcare Diagnostics, Inc.2016-02-19
BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagu recall (Z-0825-2016)Siemens Healthcare Diagnostics, Inc.2016-02-19
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog recall (Z-0754-2016)Siemens Healthcare Diagnostics, Inc2016-02-04
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analy recall (Z-0755-2016)Siemens Healthcare Diagnostics, Inc.2016-02-04
Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac tr recall (Z-0609-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement recall (Z-0610-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic recall (Z-0611-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement recall (Z-0612-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB is recall (Z-0613-2016)Siemens Healthcare Diagnostics Inc2016-01-07
Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calib recall (Z-0614-2016)Siemens Healthcare Diagnostics Inc2016-01-07
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