FDA Device recall Z-2736-2024
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived
- FDA Device
- Class II
- ongoing
- Published 2024-09-04
On 2024-09-04 the FDA classified a Class II recall of Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived by Abbott Diagnostics Technologies As, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2736-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-17 |
| Published | 2024-09-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Diagnostics Technologies As |
| Distribution | US |
Product
Afinion 2 Analyzer, model #1116986, US refurbished, CLIA waived.
Reason
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.
Identifiers
| code_info | Lot #433706, Serial numbers AF20008880, AF20002691, AF20035414, AF20015543 and AF20035460; UDI-DI: 07070060014708. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2736-2024%22
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