Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Roche. FDA records under 4 spellings of its name, each linked to the record. See the Roche group view.
As of Nov 13, 2026, FDA's public records list Roche Diagnostics Operations, Inc. with 127 device recalls and 21 510(k) clearances. The most recent is a device recall dated Jan 20, 2026: cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample su….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jan 20, 2026 | cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSClass II · Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas | Device recalls |
| Nov 21, 2025 | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescenClass II · Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to dela | Device recalls |
| Jan 24, 2025 | Tina-quant Lipoprotein(a) Gen.2 MolarityK241220 · DFC | 510(k) clearances |
| Oct 17, 2024 | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test for total L-homocysteinClass II · Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Assay can produce erroneou | Device recalls |
| Aug 15, 2024 | Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determination of creatine kinClass II · Creatine Kinase (CK) Assay Abnormal calibrations on the cobas¿ c 311/501/502 and COBAS INTEGRA 400 plus Analyzers may le | Device recalls |
| Feb 20, 2024 | ONLINE TDM MethotrexateK233454 · LAO | 510(k) clearances |
| Oct 3, 2023 | Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311, 501 and 502; INTEClass II · Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples. | Device recalls |
| Dec 12, 2022 | cobas infinity central lab, Material Number 07154003001Class II · A complaint investigation revealed that an incorrect behavior relating to the rejection of orders capability of the Host | Device recalls |
| Jul 14, 2022 | cobas e801 Immunoassay AnalyzerClass II · Software issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are c | Device recalls |
| Oct 18, 2021 | Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of the cobas u 601 urineClass II · A potential risk for false negative nitrite results exists when endogenous creatinine levels are 15,000 mg/L and above. | Device recalls |
| Mar 26, 2020 | Tina-quant Hemoglobin A1cDx Gen.3K193053 · PDJ | 510(k) clearances |
| Feb 21, 2020 | Tina-quant C-Reactive Protein IVK192072 · DCN | 510(k) clearances |
| Feb 8, 2019 | Ammonia IIK183517 · JIF | 510(k) clearances |
| Nov 5, 2018 | Tina-quant Transferrin ver.2 (urine application)K182095 · DDG | 510(k) clearances |
| Jul 28, 2017 | cobas HbA1c Test, cobas b 101 systemK163633 · LCP | 510(k) clearances |
| May 10, 2017 | ALP IFCC Gen.2K171080 · CJE | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
