Home › Roche Molecular Systems, Inc. › COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test
Roche Molecular Systems, Inc. · Model 03568555190 · UDI-DI 00875197001983
MZP
Prescription
4
510(k) clearances
197
Adverse events (1 deaths)
11
Recalls
9
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-30 | Abbott Molecular, Inc. | Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit. |
| 2022-07-19 | Abbott Molecular, Inc. | Incorrect optical calibration |
| 2021-12-06 | Abbott Molecular, Inc. | There is a software issue associated with the ability to properly complete a Field Service Engineer Maintenance and Diagnostics procedure. |
| 2021-12-06 | Abbott Molecular, Inc. | There is a software defect that can cause the Amplification Detection clamp CLEAN position to be set too high. |
| 2021-12-06 | Abbott Molecular, Inc. | There is a potential for abnormal (non-sigmoidal) amplification curves. |
| 2021-12-06 | Abbott Molecular, Inc. | There is an issue with the installation of updated camera firmware on the system. |
| 2011-04-14 | Roche Molecular Systems, Inc. | The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence |
| 2011-04-14 | Roche Molecular Systems, Inc. | The COBAS Ampliprep/COBAS TaqMan HCV Test has been shown to under-quantitate a subset of genotype 4 patient specimens by approximately 1.0-1.5 log 10 in the absence of any sequence |
| 2007-05-21 | Roche Molecular Systems, Inc. | For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent sta |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.