Recall Z-2209-2012 ยท JJF Analyzer, Chemistry, Micro, For Clinical Use
Roche Molecular Systems, Inc.
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.
| Date | Aug 15, 2012 (initiated Feb 1, 2012) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | On 1/17/2012 an "Analyzer Bulletin" notification was sent to Roche affiliates and on 2/1/2012 an "Analyzer Bulletin" notification was sent to all affected US Consignees. The notification described the product issue and provided recommended actions. Customers were referred to Roche Technical Support at 800-526-1247 for questions. |
| Quantity | 2,132 boxes |
| Distribution | Nationwide Distribution (USA). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.