Power supply provided with Afinion 2 — Class II medical device recall Z-2192-2020
Ongoing recall by Abbott Diagnostics Technologies AS, reported 2020-06-10, distributed in GA, NJ. The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the ana
| Recall number | Z-2192-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Diagnostics Technologies AS, Oslo, N/A, Norway |
| Recall initiated | 2020-03-23 |
| Classified | 2020-05-29 |
| Reported by FDA | 2020-06-10 |
| Distributed | GA, NJ |
| Countries outside the US | AR, AU, BD, BR, CA, CH, CL, CN, CO, DE, DK, ES, FI, FR, GB, GT, HK, IN, IS, IT, JP, KR, LK, MX, MY, NL, NO, OM, PE, PH, PK, PL, SA, SE, SG, TH, TT, TW, ZA |
| Quantity | 42,237 instruments |
| Model numbers | 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970 and 4 more |
Product
Power supply provided with Afinion 2, Catalog numbers 1116553, 1116554, 1116556, 1116557, 1116597, 1116598, 1116663, 1116679, 1116680, 1116681, 1116682, 1116684, 1116770, 1116771, 1116772, 1116777, 1116778, 1116970, 1116971, 1116985, 1116986, IVD. The firm name on the label is Abbott Diagnostics Technologies AS, Oslo, Norway. Power supply provided with Alere Afinion AS100 Analyzer, Catalog numbers 1115175, 1115390, 1116049, 1116050, 1116053, 1116054, 1116456, and 1116980. The firm name on the label is Alere Technologies AS, Oslo, Norway.
Reason for recall
The analyzer system may have an electrostatic discharge and sparking of the power supply provided with the analyzers resulting in the power supply becoming non-functional.
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-2192-2020. 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.