Siemens Healthcare Diagnostics, Inc.: 283 recalls on record

Recalls filed with 1 agency: FDA (283).

First recall on record: July 4, 2012. Most recent: August 26, 2026.

Risk classification: Class I: 13 · Class II: 238 · Class III: 32

Most recent recalls

DateAgencyProduct
February 22, 2017FDAThe Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine …Z-1216-2017
February 22, 2017FDAThe Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransfera…Z-1217-2017
February 15, 2017FDADimension¿ Ammonia Flex¿ reagent cartridge / AMM Dimension: The AMM method is an in vit…Z-1140-2017
February 8, 2017FDAIMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 1070…Z-1120-2017
December 14, 2016FDAADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.Z-0723-2017
November 23, 2016FDADimension Vista IRON Flex reagent cartridgesZ-0401-2017
November 23, 2016FDAADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Cent…Z-0612-2017
November 23, 2016FDAADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Cent…Z-0613-2017
November 2, 2016FDAIMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 test…Z-0319-2017
October 19, 2016FDAADVIA Centaur XPT Immunoassay SystemZ-0072-2017
October 19, 2016FDASIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KR…Z-0082-2017
September 21, 2016FDASiemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093…Z-2798-2016
September 14, 2016FDAADVIA Centaur¿ PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 …Z-2742-2016
September 7, 2016FDAADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry H…Z-2704-2016
June 8, 2016FDADimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V…Z-1886-2016
June 8, 2016FDADimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.…Z-1885-2016
May 18, 2016FDADimension Assays: Direct HDL Cholesterol (AHDL)Z-1659-2016
May 18, 2016FDADimension Assays: Triglycerides (TGL)Z-1661-2016
May 18, 2016FDADimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an …Z-1622-2016
March 30, 2016FDASiemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 1049144…Z-1240-2016
March 30, 2016FDAIMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (…Z-1243-2016
January 13, 2016FDASiemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagno…Z-0611-2016
January 13, 2016FDASiemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in con…Z-0619-2016
September 30, 2015FDASiemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 …Z-2813-2015
September 2, 2015FDADimension Vista B¿2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The…Z-2450-2015

Questions about this company

How many recalls does Siemens Healthcare Diagnostics, Inc. have?
Recalert has 283 U.S. recalls on record for Siemens Healthcare Diagnostics, Inc., published between July 4, 2012 and August 26, 2026.
Which agencies have handled Siemens Healthcare Diagnostics, Inc. recalls?
Siemens Healthcare Diagnostics, Inc. appears as the recalling firm in recalls from: FDA (283).

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