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
October 24, 2018FDAAtellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-compon…Z-0189-2019
October 24, 2018FDAAtellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnosti…Z-0116-2019
May 16, 2018FDAIMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)Z-1677-2018
May 16, 2018FDAIMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi GastrinZ-1681-2018
May 16, 2018FDAIMMULITE ¿ /IMMULITE 1000 ¿ GastrinZ-1680-2018
May 16, 2018FDAIMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)Z-1691-2018
May 16, 2018FDAIMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBcZ-1675-2018
May 16, 2018FDADimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Heal…Z-1660-2018
May 9, 2018FDAAnalyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical…Z-1588-2018
May 2, 2018FDAADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. …Z-1486-2018
December 6, 2017FDADimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920…Z-0175-2018
December 6, 2017FDADimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921…Z-0176-2018
June 28, 2017FDADimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridgeZ-2611-2017
May 24, 2017FDAADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in…Z-2086-2017
May 17, 2017FDARAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-…Z-2040-2017
April 12, 2017FDAADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays incl…Z-1712-2017
April 12, 2017FDASiemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR…Z-1748-2017
March 29, 2017FDAADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADV…Z-1537-2017
March 15, 2017FDAADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: …Z-1418-2017
March 15, 2017FDAIMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 103…Z-1421-2017
March 15, 2017FDAIMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 103…Z-1420-2017
March 15, 2017FDADimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 104617…Z-1419-2017
March 8, 2017FDASiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack…Z-1254-2017
March 8, 2017FDASiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack…Z-1256-2017
March 8, 2017FDASiemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack…Z-1255-2017

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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