Every recall we track for Roche Molecular Systems, Inc. — 14 in all — plus the complaints and injury reports the public filed about them.
Roche recalls cobas SARS-CoV-2 and Influenza A/B tests for false negative Flu A results, causing unnecessary testing and delays in treatment. Affected units have material number 09233474190.
Roche recalls cobas Influenza A/B & RSV tests for false negative results, which may delay flu treatment. Affected units sold with cobas 6800/8800 systems.
Roche recalls cobas SARS-CoV-2 and Influenza A/B tests that may produce false negative results, causing unnecessary testing and delays in treatment. Affected tests were sold with specific model numbers and lot dates.
Roche recalls cobas 5800 PCR instruments with Material No. 08707464001 due to reported false positives and invalid results, potentially causing delayed diagnoses.
Roche recalls a small number of cobas Liat analyzer units with high noise levels causing false positive Influenza B results. Affected units have specific serial numbers and material numbers.
Roche recalls cobas EGFR Mutation Test v2 due to false mutation results for Ex20Ins mutations, potentially leading to incorrect cancer treatment decisions. Affected units include all lot numbers of the system.
Roche recalls cobas SARS-CoV-2 & Influenza A/B Test for false positive results. Affected units have Catalog Number 09211101190 and Lot 10119Z.
Roche recalls cobas SARS-CoV-2 and Influenza A/B assay reagents that may produce false positive results for coronavirus and flu tests. Affected units include all lots of the cobas Liat system reagents.
Roche recalls cobas Liat Analyzer respiratory virus panel due to potential false positive results for SARS-CoV-2, Influenza A, and B tests. Affected units may show abnormal PCR growth curves.
Roche recalls uPath software versions 1.1 and 1.1 IVD-INSW due to incorrect measurement calculations when viewing slides in Split View mode at different magnifications.
Roche recalls cobas z 480 analyzers for possible false positive results due to dirty lenses. Lab users should check lens cleanliness and follow manufacturer instructions.
Roche recalls MagNA Pure 96 clinical sample concentrators used with Sample Transfer protocol 3.0 due to cross-contamination risk. Affected units may cause erroneous lab results.
Roche recalls MagNA Pure 24 System due to reported cross-contamination of samples during rack-based purification runs. Affected units have specific model numbers and were sold for clinical use.
Roche recalls certain MRSA/SA test kits due to potential reduced accuracy, risking missed infections. The US is unaffected as these tests aren't available here.
