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Roche Diagnostics Operations, Inc. FDA Recalls
13 recalls on file across devices, 0 of them Class I and 10 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464Class IIJan 20, 2026Software defect, which allows the system to accept erroneous |
| The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and elClass IINov 21, 2025Issues identified: 1) Results vary by Instrument Platform; 2 |
| cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on cobas c 701/702, in vitro test forClass IIOct 17, 2024Abnormal calibration signals and control recovery issues on |
| Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS INTEGRA 400 plus-In vitro test for the quantitative determinaClass IIAug 15, 2024Creatine Kinase (CK) Assay Abnormal calibrations on the coba |
| Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 31Class IIOct 3, 2023Elevated results were detected with Li-heparin plasma sample |
| cobas infinity central lab, Material Number 07154003001Class IIDec 12, 2022A complaint investigation revealed that an incorrect behavio |
| cobas e801 Immunoassay AnalyzerClass IIJul 14, 2022Software issue resulting in signals and sample test results |
| Cobas u 601 urinalysis test system, Catalog number 06334601001 The cobas U 601 urinalysis test system is comprised of tClass IIOct 18, 2021A potential risk for false negative nitrite results exists w |
| cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001Class IIJun 24, 2021Under specific circumstances created by the user, the cobas |
| IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for thClass IIApr 26, 2021Roche received several complaints regarding increased contro |
| Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardiaClass IIApr 7, 2021Recall reason is possible sporadic false negative convention |
| Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infClass IIApr 7, 2021Recall reason is possible sporadic false negative convention |
| 9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionizClass IIJan 6, 2021May display Calcium results on the screen with wrong arrow d |