Afinion 2 Analyzer — Class II medical device recall Z-2736-2024
Ongoing recall by Abbott Diagnostics Technologies AS, reported 2024-09-04, distributed nationwide. Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to cus
| Recall number | Z-2736-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diagnostics Technologies AS, Oslo, Norway |
| Recall initiated | 2024-06-17 |
| Classified | 2024-08-27 |
| Reported by FDA | 2024-09-04 |
| Distributed | Nationwide (US) |
| Quantity | 5 analyzers |
| UPC / GTIN / UDI-DI | 07070060014708 |
| Lot numbers | 433706 |
| Serial numbers | AF20002691, AF20008880, AF20015543, AF20035414, AF20035460 |
| Model numbers | 1116986 |
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Reason for recall
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
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-2736-2024. 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.