Every recall we track for Roche Diagnostics Operations, Inc. — 44 in all — plus the complaints and injury reports the public filed about them.
Roche recalls cobas pro integrated solutions with cobas c 503 analytical units due to a software defect that may cause incorrect lab results for specific tests, posing a remote risk of serious health issues.
Roche recalls Elecsys Anti-TSHR immunoassay kits due to inconsistent results across instruments and calibrator variations, which may lead to delayed or incorrect thyroid treatment. Affected lots: 08496633190 (exp 02/26), 08496633190 (exp 10/26), 08496609190 (exp 05/26).
Roche recalls cobas HCYS Homocysteine Assay (Material REF 06542921190) for potential erroneous patient test results. Affected units sold with cobas c 701/702 devices.
Roche recalls CK tests for cobas c 311/501/502 and COBAS INTEGRA 400 plus analyzers due to potential calibration errors causing misdiagnosis. Affected lots expire June 2024.
Roche recalls Tina-quant D-Dimer Test System with material numbers 03001245322 and others due to elevated results when using Li-heparin plasma samples. Affected units include specific cobas and Integra models.
Roche recalls specific cobas infinity central lab software versions that may mismatch patient samples due to a configuration error. Affected units must be checked for specific settings.
Roche recalls cobas e801 Immunoassay Analyzers with software issue causing inaccurate Pre-Wash test results. Affected units have specific serial numbers and catalog numbers. Consumers should contact Roche for details.
Roche recalls Cobas U 601 urinalysis test systems with potential false negative nitrite results at high creatinine levels. Affected units may require testing adjustments.
Roche recalls cobas infinity lab software versions 3.01.03 to 3.02.08 due to potential false positive or negative test results in specific user scenarios. Affected systems may need software updates to prevent incorrect lab results.
Roche recalls Iron Gen 2 reagent cassettes for inaccurate iron test results on certain analyzers. Affected units may show elevated results or control recovery issues. Consumers should contact Roche for details.
Roche recalls Elecsys Troponin I Immunoassay (Catalog# 05094810160) due to possible false negative results in heart tests when used with specific cobas e601/e602 modules. Affected users should contact Roche for details.
Roche recalls Elecsys Troponin I STAT Immunoassay (Catalog# 05094798160) due to possible false negatives in heart attack tests when used with specific analyzers. Affected units may not detect heart attacks correctly.
Roche recalls 9180 Electrolyte Analyzer units with serial numbers listed in the record. The device may display calcium results with incorrect arrow direction, potentially leading to misinterpreted results and incorrect medical decisions.
Roche recalls Cobas Infinity calculators for clinical use due to a software error that may remove serum indices flags, risking unreliable test results. Affected units include all versions from cobas infinity 3.00.0:00 onwards.
Roche recalls cobas 8000 modular analyzers with specific serial numbers for potential incorrect test results due to configuration settings. Affected units may not flag poor sample quality, leading to undetected discrepancies in test results.
Roche recalls specific chemistry analyzers that may produce incorrect test results if configuration settings are changed, affecting clinical testing accuracy.
Roche recalls professional CoaguChek XS Prof meters for possible misinterpretation of INR results as %Quick or seconds. Healthcare providers should verify display settings to avoid incorrect warfarin monitoring.
Roche recalls CoaguChek XS PST Meters for possible misinterpretation of blood clotting results, affecting patients using anticoagulants. Ensure your meter displays INR results correctly.
Roche recalls cobas c 503 analyzers for inaccurate therapeutic drug monitoring results due to residual reagent transfer during testing. Affected units have specific catalog numbers.
Roche recalls Tina-quant C-Reactive Protein Gen 3 (catalog 0517237:42402301) due to low quality recovery and invalid calibrations from cross contamination between reagents.
Roche recalls cobas infinity software versions 3.00.00+ for potential incorrect lab results due to QC status errors. Affected units include specific serial numbers listed in the recall notice.
Roche recalls all BenchMark ULTRA Advanced Staining System units due to potential fluid leaks causing electrical shorts, heat, smoke, and fire risks. Affected units may need repair or replacement.
Roche recalls all Discovery Ultra Advanced Staining Systems (RUO) due to potential fluid leaks causing electrical shorts, heat, smoke, and fire. No remedy specified in official notice.
Roche recalls Tina-quant Complement C4 ver.2 (Catalog : 05991994190) due to yellow discoloration from cross contamination between reagents, causing invalid calibrations.
Roche recalls Albumin Gen.2 (Catalog 05166861190) due to yellow discoloration from cross contamination between reagents, causing invalid calibrations and low quality recovery.
Roche recalls Elecsys Anti-TPO Assay for cobas e 411/601/602 analyzers due to RF interference claims not meeting standards. All current and upcoming lots affected.
Roche recalls specific lots of Elecsys CA 19-9 reagent for possible false high results affecting pancreatic cancer monitoring. Affected lots include 416245 and others listed. No action needed for most users.
Roche recalls cobas infinity core calculator modules for clinical use where alarm flags with < symbol don't display on validation screen. All software versions affected.
Roche recalls Elecsys Anti-HAV IgM assay due to software error causing inaccurate hepatitis A test results. Affected units have specific catalog numbers and software versions.
Roche recalls Cobas Infinity lab software versions 2.4.1 to 2.5.4 due to incorrect alarm mapping that could lead to missed clinical alerts.
Roche recalls homocysteine test kits for cobas c701/702 systems due to calibration failures. Affected lots may give inaccurate results. Contact Roche for details.
Roche recalls Cobas c Bilirubin Total Gen.3 test kits due to potential quality control issues affecting results. Affected units have catalog number 05795419190 and lot # 36133801. No remedy specified in recall notice.
Roche recalls specific albumin test kits due to potential quality control issues affecting accuracy. Affected lots include 33962301 and 37437: 12/20/19 expansion.
Roche recalls cobas c 311, c 501, c 502, and Integra 400 Plus analyzers due to potential RF interference with sTfR assays. Affected units have catalog number 20763454122 and all serial numbers.
Roche recalls cobas c 701 and 702 analyzers due to potential RF interference with sTfR assays. Affected units have catalog number 05950821190 and all serial numbers.
Roche recalls AssayTip/AssayCup Trays for cobas e 801 modules due to potential incorrect patient results from abnormal internal structure. Affected units include specific catalog and lot numbers.
Roche recalls cobas c 311 and cobas c 501/502 analyzers for inaccurate vancomycin test results. All units with catalog # 06779344190 are affected.
Roche recalls vancomycin testing devices that may give low sample results. Affected units include cobas c 311 and cobas c 501/502 analyzers with catalog # 06779336190.
Roche recalls Cobas 8000 Modular Analyzer modules with potential high pressure solenoid valve quality issues. Affected units include specific part and serial numbers listed in the recall notice.
Roche recalls cobas c51:3 analyzers with serial numbers 1731-08 and 1722-03 due to potential quality issues with high pressure solenoid valves.
Roche recalls cobas e 601 modules (part 04745922001) for potential inaccurate test results from a quality issue with high pressure solenoid valves.
Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, E 170, and other analyzers. Affected lots were distributed from February 2019 to July 2019.
Roche recalls specific lots of Elecsys Anti-CCP assay kits for performance issues with cobas e 411, e 170, and other analyzers. Affected lots distributed from Feb 2019 to July 2019.
Roche recalls Tina-Quant Myoglobin Gen 2 Tests (lot 349860+) due to calibration failures and QC imprecision from signal drop in reaction kinetics. Affected units may produce inaccurate results.
