Manufacturer
42 recalls in our database name Roche Molecular Systems, Inc. as the manufacturing or recalling firm.
Of the 42 recalls from Roche Molecular Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (2%) 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 Molecular Systems is recalling 425 cobas 4800 systems because rare channel-shift errors may cause test results to be reported in the wrong channel.
Roche is recalling COBAS TaqMan MTB Test Definition Files due to an incorrect cutoff value that may cause false negative results for tuberculosis tests.
Roche is recalling 7 COBAS AmpliPrep instruments because the sample clot detection feature was disabled during quality control, potentially allowing unflagged clotted samples to be processed.
Roche Molecular Systems is recalling 13 MagNA Pure 96 Systems due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.
Roche Molecular Systems is recalling 816 MagNA Pure LC instruments due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling DataInnovations Instrument Manager software due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling 77 COBAS 8000 modular analyzers nationwide due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling DataCara GM software due to a device-associated diagnostic issue. 479 units were distributed nationwide.
Roche Molecular Systems is recalling 126 units of DataCare POC software due to a device-associated diagnostic issue.
Roche Molecular Systems is recalling 1,213 LightCycler 2.0 instruments due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling Data Station AMPLILINK software due to a device-associated diagnostic software issue. The software is used with various COBAS instruments for molecular diagnostics.
Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.
Roche Molecular Systems is recalling 44 kits of the cobas 4800 BRAF V600 Mutation Test because internal-use controls were incorrectly packaged into the product.
Roche Molecular Systems is recalling Amplilink Software 3.2.3 because it may assign wrong results to orders when used with certain Laboratory Information Systems.
Roche Molecular Systems is recalling certain lots of COBAS AmpliPrep barcode clips because they can cause sample tubes to stick, leading to aborted instrument runs.
Roche Molecular Systems is recalling specific lots of the Cobas KRAS Mutation Test because stability testing showed the kits trended toward the upper specification limit for codon 61 peak height ratio.