Product Wiki · Recalls · U.S. FDA — Device Enforcement

Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA… — recall Z-2403-2012

U.S. FDA — Device Enforcement · United States · 2012-04-23 · Class II

As described by U.S. FDA — Device Enforcement: 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.

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2403-2012
Date of alert
2012-04-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Roche Molecular Systems, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide (USA) Distribution
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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