Recall Z-0484-2013— Roche Molecular Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Roche Molecular Systems, Inc., initiated 2012-07-16, terminated 2015-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: Roche Molecular Systems, Inc. has become aware of a device-associated diagnostic software issue..
- Recalling firm
- Roche Molecular Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-07-16
- Terminated
- 2015-07-22
- Firm location
- Branchburg, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.