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U.S. Department of Health and Human Services

Class 2 Device Recall COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 CEIVD

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  Class 2 Device Recall COBAS Ampliprep/COBAS TaqMan HBV v2.0 USIVD COBAS Ampliprep/COBAS TaqMan HBV v2.0 CEIVD see related information
Date Initiated by Firm December 28, 2010
Date Posted March 01, 2011
Recall Status1 Terminated 3 on August 27, 2012
Recall Number Z-1459-2011
Recall Event ID 57560
Product Classification Hepatitis viral b dna detection - Product Code MKT
Product COBAS AmpliPrep/COBAS TaqMan HBV v2.0 US-IVD;
COBAS AmpliPrep/COBAS TaqMan HBV v2.0 CE-IVD
Code Information Catalog number 05027012190, 05393850190, 05393850190, 05393868190 Lot #K11236, K15440, L00846, M05135, M11190, M12625, M14232, N00159, N02341, N05553, N05554, N07543, N08567
Recalling Firm/
Roche Molecular Systems, Inc.
1080 Us Highway 202 S
Somerville NJ 08876-3733
For Additional Information Contact Vincent C. Stagnitto
Manufacturer 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.
FDA Determined
Cause 2
Employee error
Action 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.
Quantity in Commerce 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, Egypt, Finland, France, Germany, Ghana, Greece, Hong Kong, India, Israel, Italy, Japan, Kuwait, Luxembourg, Malaysia, Mauritania, Mongolia, Netherlands, New Zealand, Norway, Poland, Romania, Saudi Arabia, Singapore, Slovakia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and the United Kingdom
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.