FDAFDA · Food and drugs·Recall number Z-2403-2012
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.
Published September 26, 2012 · Recall initiated: April 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Nationwide (USA) Distribution
- Lot
- 05666678001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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