Roche Diagnostics Operations, Inc.
FDA Regulatory Profile
Roche Diagnostics Operations, Inc. appears in FDA public data with 127 recalls, 7 510(k) clearances, 9 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1476-2026, Class II) was initiated on January 20, 2026. Its most recent 510(k) clearance was granted on January 24, 2025.
Summary
- Total Recalls
- 127
- 510(k) Clearances
- 7
- Inspections
- 9
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1476-2026 | Class II | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, m | January 20, 2026 |
| Z-1009-2026 | Class II | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated m | November 21, 2025 |
| Z-0489-2025 | Class II | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/70 | October 17, 2024 |
| Z-3187-2024 | Class II | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the qu | August 15, 2024 |
| Z-0352-2024 | Class II | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001 | October 3, 2023 |
| Z-0952-2023 | Class II | cobas infinity central lab, Material Number 07154003001 | December 12, 2022 |
| Z-1515-2022 | Class II | cobas e801 Immunoassay Analyzer | July 14, 2022 |
| Z-0266-2022 | Class II | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test syst | October 18, 2021 |
| Z-2444-2021 | Class II | cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001 | June 24, 2021 |
| Z-1675-2021 | Class II | IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: | April 26, 2021 |
| Z-1595-2021 | Class II | Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the di | April 7, 2021 |
| Z-1596-2021 | Class II | Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnos | April 7, 2021 |
| Z-1098-2021 | Class II | 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potass | January 6, 2021 |
| Z-0883-2021 | Class II | A calculator/data processing module for clinical use is an electronic device intended to store, retr | December 17, 2020 |
| Z-0754-2021 | Class II | Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 mod | December 8, 2020 |
| Z-0755-2021 | Class II | Roche cobas pro integrated solutions (cobas pro ISE, cobas c 503, and cobas e 801 analytical units) | December 8, 2020 |
| Z-0804-2021 | Class II | CoaguChek XS PST Meters- IVD (Patient Self-Testing) measures blood-clotting time for people who are | December 2, 2020 |
| Z-0803-2021 | Class II | CoaguChek XS Prof (Professional) Meters- IVD professional healthcare providers for quantitative prot | December 2, 2020 |
| Z-0752-2021 | Class II | cobas pro integrated solutions -cobas c 503, Analyzer, chemistry (photometric discrete), for clinica | November 23, 2020 |
| Z-0634-2021 | Class II | Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quanti | November 6, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241220 | Tina-quant Lipoprotein(a) Gen.2 Molarity | January 24, 2025 |
| K233454 | ONLINE TDM Methotrexate | February 20, 2024 |
| K163633 | cobas HbA1c Test, cobas b 101 system | July 28, 2017 |
| K131366 | ACCU-CHEK AVIVA EXPERT BLOOD GLUCOSE MONITORING SYSTEM | October 11, 2013 |
| K131029 | ACCU-CHEK AVIVA PLUS TEST STRIP | August 9, 2013 |
| K121610 | COBAS C 501 TINA-QUANT HBA1CDX GEN.3 ASSAY | August 8, 2013 |
| K113072 | TINA-QUANT ALBUMIN GEN.2 | May 14, 2012 |