Company:Roche Molecular Systems, Inc
Date of Enforcement Report:8/8/2007
Class:ll
PRODUCT
a) Amplilink Software versions 1.1, 1.3, 1.4, 2.41. COBAS Amplicor CTA & NGA Tests, Recall # Z-1106-2007;
b) Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0, Catalog number 03576710190, Catalog number 20757497122, working probe suspension /IC PS1-IC4; Catalog Number 20757535122, Working substrate SB3-SB, ecall # Z-1107-2007
REASON
TFor select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard working reagent stability information reported by AMPLILINK Software (versions 1.1, 1.3, 1.4 and 2.41) and the stability information provided in the test kit package inserts/method manual.
CODE
a) and b) versions 1.1, 1.3, 1.4, 2.41
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters on May 21, 2007.
Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
5,806 units
DISTRIBUTION
Nationwidep>
