FDAFDA · Food and drugs·Recall number Z-2209-2012
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode clips hold sample input tubes in the COBAS AmpliPrep Instrument (CAP) sample racks and have a barcode to identify the sample.
Published August 22, 2012 · Recall initiated: February 1, 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
Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips. As a consequence, the CAP instrument will lift both the sample input tube together with the barcode clip from the sample rack, resulting in an aborted run. No erroneous results would be produced if the issue occurs, but samples in proce
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Roche Molecular Systems, Inc.
- Distributor
- Nationwide Distribution (USA).
- Lot
- Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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