Siemens Healthcare Diagnostics: 26 recalls on record

Recalls filed with 1 agency: FDA (26).

First recall on record: January 16, 2013. Most recent: October 29, 2014.

Risk classification: Class II: 23 · Class III: 3

Most recent recalls

DateAgencyProduct
October 29, 2014FDAIMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD…Z-0122-2015
October 8, 2014FDAADVIA Centaur XP Immunoassay System (including refurbished units), This system is int…Z-2716-2014
October 8, 2014FDAADVIA Centaur Immunoassay System (including refurbished units), This system is intend…Z-2715-2014
September 24, 2014FDAADVIA Centaur XP Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10285…Z-2663-2014
September 24, 2014FDAADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalo…Z-2643-2014
September 24, 2014FDAADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980…Z-2662-2014
May 14, 2014FDAADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog #…Z-1553-2014
May 7, 2014FDAIMMULITE/IMMULITE 1000 Systems Androstenedione (Test Code AND), REF LKAO1, SMN 10381158, …Z-1531-2014
May 7, 2014FDAIMMULITE 2000/2000 XPi Systems Androstenedione (Test Code AND), REF L2KAO2, SMN 10381188,…Z-1532-2014
May 7, 2014FDAIMMULITE 2000 /IMMULITE 2000 XPi Systems TIE Total IgE, REF L2KIE2, SMN 10380873, and L2K…Z-1518-2014
May 7, 2014FDAIMMULITE /IMMULITE 1000 Systems TIE Total IgE, REF LKIE1, SMN 10380867, IVD --- Siemens H…Z-1517-2014
February 5, 2014FDAT3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) …Z-0868-2014
February 5, 2014FDAT3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an …Z-0867-2014
January 1, 2014FDAIMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siem…Z-0569-2014
November 27, 2013FDAADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistrie…Z-0346-2014
November 27, 2013FDAADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specia…Z-0344-2014
November 27, 2013FDASiemens Chemistry Calibrator (CAL) used with the ADVIA Chemistry Direct Bilirubin_2 Reage…Z-0365-2014
November 27, 2013FDAADVIA 1200 System Software: 1) V2.00, 2) V2.01. Performs assays for general and specia…Z-0343-2014
November 27, 2013FDAADVIA 1800 System Software V2.01. Performs assays for general and specialty chemistrie…Z-0345-2014
October 23, 2013FDAADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 an…Z-0011-2014
September 11, 2013FDAADVIA Chemistry A1c_3 Calibrators, Catalog Number 10491408, IVD --- COMMON/USUAL NAME: AD…Z-2135-2013
September 4, 2013FDAPSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers, Catalog Numbers LKPS1…Z-2047-2013
September 4, 2013FDAADVIA 120 Hematology Analyzer, Catalog Numbers SMN 10360958 and 10360959 . The ADVIA 1…Z-2114-2013
January 16, 2013FDAImmunoradiometric assay.Z-0647-2013
January 16, 2013FDAImmunoradiometric assay. Device is an immunoradiometric assay designed for the quantit…Z-0646-2013

Questions about this company

How many recalls does Siemens Healthcare Diagnostics have?
Recalert has 26 U.S. recalls on record for Siemens Healthcare Diagnostics, published between January 16, 2013 and October 29, 2014.
What was the most recent Siemens Healthcare Diagnostics recall?
FDA recall Z-0122-2015, published October 29, 2014: IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement mea…
Which agencies have handled Siemens Healthcare Diagnostics recalls?
Siemens Healthcare Diagnostics appears as the recalling firm in recalls from: FDA (26).

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