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Hepatitis Viral B Dna Detection
FDA product code MKT · Class 2 · Microbiology
23
Registered devices
45
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.Alinity m — ABBOTT MOLECULAR INC.Alinity m — ABBOTT MOLECULAR INC.COBAS® TaqMan® HBV Test, For Use With The High Pure System — Roche Molecular Systems, Inc.DOCKING STATION SHORT — Roche Molecular Systems, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System — Roche Diagnostics GmbHRealTime — ABBOTT MOLECULAR INC.cobas® HBV — Roche Molecular Systems, Inc.Alinity m — ABBOTT MOLECULAR INC.Aptima® — Hologic, Inc.COBAS® AmpliPrep / COBAS® TaqMan® Wash Reagent — Roche Molecular Systems, Inc.cobas® HIV1 Quantitative nucleic acid test for use on the cobas® 68 88 Systems — Roche Diagnostics GmbHAptima® — Hologic, Inc.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.High Pure System Viral Nucleic Acid Kit — Roche Molecular Systems, Inc.COBAS® AmpliPrep / COBAS® TaqMan® HBV Test, v2.0 — Roche Molecular Systems, Inc.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.RealTime — ABBOTT MOLECULAR INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-04 | Abbott Molecular, Inc. | There is a potential for misquantitation high results for negative samples. |
| 2022-03-04 | Abbott Molecular, Inc. | There is a potential for misquantitation high results of negative samples. |
| 2016-07-15 | Roche Diagnostics Operations, Inc. | Roche has received four reports of injury caused by the sharp edge of the center guide rail of an analyzers sample rack tray. The cleaning procedure for the sam |
| 2010-12-28 | Roche Molecular Systems, Inc. | There is an issue regarding liquid level detection of the CS1 Magnetic Glass Particles (MGP) Reagent Cassette of the COBAS AmpliPrep /COBAS TaqMan HBV v2.0 Test |
| 2010-12-20 | Abbott Molecular | Internal testing identified the potential of under filled and over filled enzyme reagent vials which may result in obtaining less than the total number of tes |
| 2007-06-13 | Medtronic Emergency Response Systems, Inc. | Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J. |
| 2004-08-02 | Zoll Medical Corporation | Visual Sreen display and audible prompt may not advise to 'Press Shock' |
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