COBAS AmpliPrep Sample Tube Input Barcode Clips, catalog number 03137040001. Input S-tube barcode...
FDA Device Recall #Z-2209-2012 — Class II — February 1, 2012
Recall Summary
| Recall Number | Z-2209-2012 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 1, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Roche Molecular Systems, Inc. |
| Location | Branchburg, NJ |
| Product Type | Devices |
| Quantity | 2,132 boxes |
Product Description
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 for Recall
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
Distribution Pattern
Nationwide Distribution (USA).
Lot / Code Information
Lot Numbers: 11049503, 11053503, 11054503, 11525503 and 11526503.
Other Recalls from Roche Molecular Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1104-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative as... | Dec 21, 2022 |
| Z-1106-2023 | Class II | cobas Influenza A/B & RSV UC (Utility Channel) ... | Dec 21, 2022 |
| Z-1105-2023 | Class II | cobas SARS-CoV-2 & Influenza A/B Qualitative nu... | Dec 21, 2022 |
| Z-0097-2023 | Class II | cobas 5800 instrument, Material No. 08707464001... | Sep 8, 2022 |
| Z-0828-2022 | Class II | cobas LiatSystem, respiratory virus panel nucle... | Nov 16, 2021 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.