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Terminated

Amplilink Software Versions 1.1, 1.3, 1.4, 2.41 COBAS AmpliPrep/COBAS Amplicor HCV Test, version 2.0

FDA Recall Z-1107-2007 · Posted 2007-08-02

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeMZP
Date Initiated2007-05-21
Date Terminated2010-02-18
Product Quantity5,806 total

Reason for Recall

For 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.

Firm Action

Urgent Medical Device Correction letters were mailed on 5/21/07 by first class mail. Letters describe the discrepancy between software reagent expiration dates and package insert expiration dates.

Root Cause

Other

Distribution Pattern

Nationwide to hospitals and laboratories.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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