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Terminated

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.

FDA Recall Z-2403-2012 · Posted 2012-09-18

Recalling FirmRoche Molecular Systems, Inc.
Recall StatusTerminated
Product CodeOYT
Date Initiated2012-04-23
Date Terminated2014-02-12
Product Quantity1292 instruments

Reason for Recall

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.

Firm Action

Roche Molecular Systems Inc. sent "Urgent Field Safety Notice" letters and Faxback forms on 4/23/2012 via UPS to all affected customers. The issue was described and recommended actions were provided. A Product Advisory Notice and an Updated Field Safety Notice were issued as well.

Root Cause

Device Design

Distribution Pattern

Nationwide (USA) Distribution

Official Source

View FDA Recall →

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

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