AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001,
FDA device recall Z-1928-2009 · posted 2009-08-27 · Terminated
Recall details
- Recalling firm
- Roche Molecular Systems, Inc.
- Reason for recall
- Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and
- Action taken
- Urgent Medical Device Correction Letters were sent on June 2, 2009 by first class mail. The letter described the issue; impact on results; clinical implications; the workaround; and the actions required, which include following the workaround until a new version of AMPLILINK software is available and filing the letter for future reference. Questions or concerns should be directed to Roche Diagnostics Technical Support at 1-800-526-1247.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JJH
- Quantity affected
- 282
- Distribution
- Nationwide Distribution
- Date initiated
- 2009-06-02
- Date posted
- 2009-08-27
- Date terminated
- 2010-08-13
- Location
- Somerville, NJ
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