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cobas® HBV Quantitative nucleic acid test for use on the cobas® 6800/8800 System
Roche Diagnostics GmbH · Model 07000979190 · UDI-DI 00875197004885
0
510(k) clearances
45
Adverse events
7
Recalls
9
Facilities
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 sample rack tray has be |
| 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 on the COBAS AmpliP |
| 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 tests per kit as descri |
| 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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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.