Company:Roche Molecular Systems, Inc.
Date of Enforcement Report 9/26/12
Class ll:
PRODUCT
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System. Recall Number Z-2403-2012
REASON
When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
RECALLING FIRM/MANUFACTURER
Roche Molecular Systems, Inc., Branchburg, NJ on 4/23/2012. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1292 instruments
DISTRIBUTION
Nationwide
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