Company: Roche Molecular Systems, Inc.
Date of Enforcement Report 1/2/2013
Class ll:
PRODUCT
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland. Recall Number Z-0614-2013
REASON
Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc, Branchburg, NJ 10/11/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Distributed in the states of GA, CA, NC, and MN.
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