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 21, 2020FDAAtellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative m…Z-0102-2021
October 21, 2020FDAADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitati…Z-0101-2021
September 9, 2020FDADimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro di…Z-2927-2020
July 8, 2020FDA(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SM…Z-2437-2020
July 1, 2020FDAADVIA Chemistry CalibratorZ-2430-2020
June 17, 2020FDAAtellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414…Z-2283-2020
June 17, 2020FDAADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number…Z-2280-2020
March 25, 2020FDAIMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (60…Z-1514-2020
March 11, 2020FDAAtellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.…Z-1435-2020
February 26, 2020FDAAtellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For i…Z-1261-2020
February 26, 2020FDADimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444Z-1233-2020
February 26, 2020FDAADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - prod…Z-1260-2020
January 29, 2020FDASiemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells …Z-0829-2020
October 30, 2019FDAAtellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN…Z-0204-2020
October 30, 2019FDAAtellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SM…Z-0205-2020
July 10, 2019FDAADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 006304…Z-1913-2019
May 8, 2019FDAAtellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462Z-1236-2019
May 8, 2019FDASiemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461Z-1235-2019
May 8, 2019FDASiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399Z-1234-2019
February 6, 2019FDAAtellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Mate…Z-0782-2019
December 26, 2018FDADimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplica…Z-0616-2019
November 21, 2018FDADimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: D…Z-0466-2019
October 31, 2018FDAAPTIO RACK INPUT MODULEZ-0210-2019
October 31, 2018FDASTREAMLAB CORE UNIT / LYNX WITH IOMZ-0215-2019
October 31, 2018FDAAPTIO 15000 REFRIGERATED STORAGE MODULEZ-0212-2019

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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