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.
Reported: September 26, 2012 Initiated: April 23, 2012 #Z-2403-2012
Product Description
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.
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.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 1292 instruments
- Distribution
- Nationwide (USA) Distribution
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Roche Molecular Systems, Inc.. Units affected: 1292 instruments.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 26, 2012. Severity: Moderate. Recall number: Z-2403-2012.
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