How many recalls does Roche Diagnostics Operations, Inc. have?

Recalert has 48 U.S. recalls on record for Roche Diagnostics Operations, Inc., published between December 12, 2012 and November 27, 2024.

What was the most recent Roche Diagnostics Operations, Inc. recall?

FDA recall Z-0489-2025, published November 27, 2024: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine

Which agencies have handled Roche Diagnostics Operations, Inc. recalls?

Roche Diagnostics Operations, Inc. appears as the recalling firm in recalls from: FDA (48).

Roche Diagnostics Operations, Inc.: 48 recalls on record

Recalls filed with 1 agency: FDA (48).

First recall on record: December 12, 2012. Most recent: November 27, 2024.

Risk classification: Class II: 45 · Class III: 3

Most recent recalls

Date	Agency	Product	Recall number
November 27, 2024	FDA	cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cob…Z-0489-2025	Z-0489-2025
October 2, 2024	FDA	Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test…Z-3187-2024	Z-3187-2024
October 21, 2020	FDA	Albumin Gen.2, Catalog 05166861190Z-0104-2021	Z-0104-2021
December 18, 2019	FDA	Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to he…Z-0669-2020	Z-0669-2020
October 16, 2019	FDA	Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c …Z-0042-2020	Z-0042-2020
September 11, 2019	FDA	cobas e 601 module (cobas 6000 Modular Series system) Part Number: 04745922001Z-2476-2019	Z-2476-2019
February 1, 2017	FDA	Tina-Quant (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) The Tina-…Z-1092-2017	Z-1092-2017
February 1, 2017	FDA	Cobas b 123 POC system The cobas b 123 POC system is a fully automated POC system for wh…Z-1077-2017	Z-1077-2017
November 2, 2016	FDA	VS II Aliquoter System calculator/data processing module, for clinical use Product Us…Z-0103-2017	Z-0103-2017
November 2, 2016	FDA	cobas p 701 Post-Analytical Unit calculator/data processing module, for clinical use …Z-0101-2017	Z-0101-2017
November 2, 2016	FDA	URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is…Z-0099-2017	Z-0099-2017
November 2, 2016	FDA	Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Anal…Z-0094-2017	Z-0094-2017
April 6, 2016	FDA	Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL,…Z-1277-2016	Z-1277-2016
March 30, 2016	FDA	cobas p 512 pre-analytical system Pre-analytical sample handling that includes de-capp…Z-1233-2016	Z-1233-2016
March 23, 2016	FDA	Accu-Chek Inform II Base Unit as a part of the Accu-Chek Inform II Blood Glucose Monitori…Z-1172-2016	Z-1172-2016
July 8, 2015	FDA	HDL-Cholesterol gen.3. For the quantitative determination of high-density lipoprotein …Z-1924-2015	Z-1924-2015
July 8, 2015	FDA	Triglycerides/Glycerol Blanked. In vitro test for the quantitative determination of tr…Z-1930-2015	Z-1930-2015
July 8, 2015	FDA	HDL-Cholesterol plus gen.3.; and Small Supersized Intended for use on COBAS Integra 80…Z-1925-2015	Z-1925-2015
July 8, 2015	FDA	Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative dete…Z-1922-2015	Z-1922-2015
July 8, 2015	FDA	Uric Acid plus ver.2 In vitro test for the quantitative determination of uric acid in …Z-1931-2015	Z-1931-2015
May 27, 2015	FDA	Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, co…Z-1622-2015	Z-1622-2015
January 7, 2015	FDA	ACCU-CHEK Tender II 13/110 10 + 10 pieces Product Usage: Intended for the infusion an…Z-0891-2015	Z-0891-2015
January 7, 2015	FDA	ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or in…Z-0887-2015	Z-0887-2015
November 5, 2014	FDA	ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Pr…Z-0146-2015	Z-0146-2015
October 22, 2014	FDA	Omni Micro-electrode/reference electrode for cobas b221 analyzer. The Roche Diagnostic…Z-0064-2015	Z-0064-2015

Questions about this company

How many recalls does Roche Diagnostics Operations, Inc. have?: Recalert has 48 U.S. recalls on record for Roche Diagnostics Operations, Inc., published between December 12, 2012 and November 27, 2024.
What was the most recent Roche Diagnostics Operations, Inc. recall?: FDA recall Z-0489-2025, published November 27, 2024: cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteine
Which agencies have handled Roche Diagnostics Operations, Inc. recalls?: Roche Diagnostics Operations, Inc. appears as the recalling firm in recalls from: FDA (48).

Do you carry products from Roche Diagnostics Operations, Inc.? Check your whole catalog free against 80,000+ recalls.

Paste up to 100 UPCs or SKUs and see which ones match a CPSC, FDA, NHTSA or FSIS recall. No account needed.

Check my catalog free

Want it checked every night instead? Starter watches 500 SKUs for $29/month. See plans

Roche Diagnostics Operations, Inc.: 48 recalls on record

Most recent recalls

Questions about this company

Do you carry products from Roche Diagnostics Operations, Inc.? Check your whole catalog free against 80,000+ recalls.

Related companies