Home › Device types › MZP
Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus
FDA product code MZP · Class 2 · Microbiology
34
Registered devices
197
Adverse events
11
Recalls
4
510(k) clearances
Devices with this code
COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0 — Roche Molecular Systems, Inc.cobas omni MGP Reagent MGP) — Roche Diagnostics GmbHcobas® HBV/HCV/HIV-1 Control Kit — Roche Diagnostics GmbHcobas omni Specimen Diluent SPEC DIL) — Roche Diagnostics GmbHRealTime — ABBOTT MOLECULAR INC.cobas omni Lysis Reagent LYS) — Roche Diagnostics GmbHAptima — Hologic, Inc.Aptima® — Hologic, Inc.RealTime — ABBOTT MOLECULAR INC.cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 System — Roche Diagnostics GmbHRealTime — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.RealTime — ABBOTT MOLECULAR INC.cobas omni Wash Reagent WASH) — Roche Diagnostics GmbHAptima — Hologic, Inc.Aptima — Hologic, Inc.RealTime — ABBOTT MOLECULAR INC.cobas® NHP Negative Control Kit — Roche Diagnostics GmbHAlinity m — ABBOTT MOLECULAR INC.VERSANT® HCV RNA 3.0 ASSAY bDNA — Siemens Healthcare Diagnostics Inc.VERSANT® HCV RNA 3.0 ASSAY bDNA — Siemens Healthcare Diagnostics Inc.Alinity m — ABBOTT MOLECULAR INC.cobas® HCV — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.
Recent 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 |
| 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 abs |
| 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 abs |
| 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 |
| 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 durin |
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