Manufacturer
39 recalls in our database name Roche Diagnostics Corporation as the manufacturing or recalling firm.
Of the 39 recalls from Roche Diagnostics Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (5%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.
Roche Diagnostics is recalling four cobas p 501 post-analytical units because the tray input flap may become loose and detach from the instrument.
Roche Diagnostics is recalling nine cobas p 701 post-analytical units because the tray input flap may become loose and detach.
Roche Diagnostics is recalling 15 units of Cobas infinity software versions 2.0 through 2.5 because quality control alarms may fail to display after a bottle change.
Roche Diagnostics is recalling 149 cobas e 801 immunoassay analyzers because signal drops after bottle changeovers may lead to incorrect medical decisions.
Roche Diagnostics is recalling Tina-quant IgM Gen.2 assays due to new endogenous interference claims that may pose a medical risk on specific analyzers.
Roche Diagnostics is recalling Bilirubin Total Gen.3 assays due to new endogenous interference claims that may pose a potential medical risk.
Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.
Roche Diagnostics is recalling 774 units of Albumin BCP reagent due to calibration failures and QC imprecision caused by elevated pH levels.
Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.
Roche Diagnostics is recalling Anti-HAV IgM test systems due to potential erroneous result messages on the cobas e 602 module.
Roche Diagnostics is recalling CoaguChek XS Prothrombin Time test strips nationwide because they may produce abnormally high INR results.
Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.
Roche is recalling 12 units of the cobas p 612 pre-analytical system because sample material may contact the pipetting nozzle, potentially causing false positive test results.
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated and non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Roche Diagnostics is recalling the Elecsys Vitamin D total II test system because it may produce falsely elevated, non-reproducible results, potentially leading to incorrect vitamin D dosage adjustments.
Roche Diagnostics is recalling 35 cobas e 801 immunoassay analyzers because a tilted syringe plunger may crack, leading to impaired syringe function.
Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.
Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.
Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.
Roche Diagnostics is recalling cobas b 221 AutoQC Modules because a software defect prevents the scheduled quality control measurements from starting.
Roche Diagnostics is recalling Acetaminophen assay method sheets for COBAS INTEGRA and MODULAR ANALYTICS systems because they omit a statement regarding potential interference from gammopathy.
Roche Diagnostics is recalling 47 units of the Elecsys BRAHMS PCT Immunoassay because it shows decreased recovery of patient samples on the cobas e 801 module compared to other analyzers.
Roche Diagnostics is recalling cobas e 601 Immunoassay Analyzers because complaints were received regarding questionable results caused by the use of 13 sample tubes without tube adapters.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Roche Diagnostics
Swiss diagnostic company
Source: Wikidata (Q1592110), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.