COBAS AmpliPrep Instrument — Class II medical device recall Z-0614-2013
Terminated recall by Roche Molecular Systems, Inc., reported 2013-01-02, distributed in CA, GA, MN, NC. Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging fea
| Recall number | Z-0614-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Molecular Systems, Inc., Branchburg, NJ, United States |
| Recall initiated | 2012-10-11 |
| Classified | 2012-12-22 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2013-09-11 |
| Distributed | CA, GA, MN, NC |
| Quantity | 7 units |
| Reason classes | software |
Product
COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland
Reason for recall
Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0614-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.