Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Reported: December 19, 2012 Initiated: July 16, 2012 #Z-0484-2013
Product Description
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.
Reason for Recall
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Details
- Recalling Firm
- Roche Molecular Systems, Inc.
- Units Affected
- 884 units
- Distribution
- Nationwide Distribution
- Location
- Branchburg, NJ
Frequently Asked Questions
What product was recalled? ▼
Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS¿ AmpliPrep instrument, COBAS¿ TaqMan¿ analyzer, COBAS¿ TaqMan¿ 48 analyzer, COBAS¿ AMPLICOR¿ analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase Chain Reaction) molecular diagnostic analytes.. Recalled by Roche Molecular Systems, Inc.. Units affected: 884 units.
Why was this product recalled? ▼
Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 19, 2012. Severity: Moderate. Recall number: Z-0484-2013.
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