Overview of recall records associated with Roche Molecular Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 22, Class III: 2.
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
The firm received customer complaints regarding false negative Influenza A (Flu A) results and late Flu A Target Ct values. A false negative influenza A result may lead to additional…
Reported false positive and invalid results on the affected devices due to anomalous baselines. This may lead to erroneous or delayed diagnoses.
Roche has identified a small number of cobas Liat analyzer units that have consistently high noise levels (background signal) originating from the amber detector (used for Influenza B…
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
Customers have reported an increased number of false positive SARS-CoV-2 results.
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on…
Invalid or false positive results for one or more targets (SARS-CoV-2/Influenza A/Influenza B) using the cobas SARS-CoV-2 & Influenza A/B assay for use under emergency use authorization on…
When a user creates a measurement tool annotation in the uPath Enterprise software version 1.1, the measurement value is incorrectly calculated when the measurement is viewed in "Split…
Dirty Lens May Cause Invalid or False Positive Results
When using Sample Transfer protocol version 3.0, the drop catcher is not activated on the MagNA Pure 96 instrument, which introduces a potential risk for cross-contamination leading to…
Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run.
The cobas MRSA/SA tests may have decreased performance compared to the analytical sensitivity for MSRA detection. A screening failure can lead to potential infection in the colonized…
The LightCycler 480 algorithm used for the LightMix Zika rRT-PCR Test, EUA (catalog number 07987897001) occasionally (~1% of the time) calls a positive result for a negative sample if there…
During internal studies using contrived plasma specimens, several mutations (L8568R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (ie False Negative ) result…
Kit labeled with the incorrect expiration date.
An error was found within the Hungarian translations of the cobas EGFR Mutation Test v2 Instructions for Use (M/N 07340761001-01HU, Doc Rev. 1.0, Dated 08/2015) and the cobas cfDNA Sample…
Due to a supplier issue, the incorrect green and amber LED components were used in the manufacture of the LED printed circuit board assemblies (PCBA) in certain cobas Liat Analyzers.
cobas KRAS Mutation Kit T10786 is generating invalid results for the Mutant Control and/or KRAS Calibrator.
Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received from different lots of the cobas ¿ PCR Urine kits, cobas ¿ PCR Female Swab kits, and cobas ¿…
During an internal investigation, a formulation error that occurred was identified during the manufacture of the cobas 4800 HPV Master Mix reagent that was packaged in four (4) cobas 4800…
In rare instances, channel shifted results have been generated with cobas 4800 assays run on v1.1.1 of the cobas 4800 system. Raw data review indicates that, in these cases, all signals are…
The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD…
This page summarizes recall records in which the official source identifies Roche Molecular Systems, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
