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COBAS® TaqMan® HBV Test, For Use With The High Pure System

Roche Molecular Systems, Inc. · Model 03577163190 · UDI-DI 00875197002003

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510(k) clearances

Adverse events

Recalls

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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Data 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.