Amplilink — Class II medical device recall Z-2403-2012
Terminated recall by Roche Molecular Systems, Inc., reported 2012-09-26, distributed nationwide. When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 seri
| Recall number | Z-2403-2012 |
|---|---|
| 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 | 2012-04-23 |
| Classified | 2012-09-18 |
| Reported by FDA | 2012-09-26 |
| Terminated | 2014-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 1,292 instruments |
| Reason classes | software |
Product
Amplilink (AL) Software 3.2.3 for use with COBAS AMPLICOR, CAP/CA, COBAS TaqMan,and COBAS AmpliPrep/COBAS TaqMan. The software can be used with a Laboratory Information System.
Reason for recall
When using a Laboratory Information system (LIS) with automated systems utilizing AMPLILINK software v3.2 series (AL v3.2) there is a potential for wrong results to be assigned to an order.
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-2403-2012. 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.