COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD; COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
FDA device recall Z-1459-2011 · posted 2011-03-01 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- 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 AmpliPrep instrument.
- Action taken
- Roche sent Urgent Medical Device Correction Letters to their consignees on December 28, 2010 via Fed Ex. The letters advise the customers to verify the correct configuration of the CSI reagent cassette, remind customers to follow the package insert instructions for including all required controls for each batch and advise that review of previously generated results may be warranted. A UMDC Faxback form was attached for the consignee to complete. For questions regarding this recall call 908-253-7569.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MKT
- Quantity affected
- 93 kits to US; 22,119 kits to foreign
- Distribution
- Worldwide Distribution - USA including CA, CT, IN, MI, MN, NC, NE, NY, OR, TX, WA, and WI and the countries of Australia, Austria, Azerbaijan, Belgium, Brazil, Canada, China, Croatia, Czech Republic,
- Date initiated
- 2010-12-28
- Date posted
- 2011-03-01
- Date terminated
- 2012-08-27
- Location
- Somerville, NJ
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