FDA Device recall Z-2209-2012
COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001
- FDA Device
- Class II
- terminated
- Published 2012-08-22
On 2012-08-22 the FDA classified a Class II recall of COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001 by Roche Molecular Systems, citing 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,….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2209-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-01 |
| Published | 2012-08-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Roche Molecular Systems |
| Distribution | US |
Product
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.
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
Identifiers
| code_info | Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2209-2012%22
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