Abbott Alinity m SARS-CoV-2 CTRL Kit — Class II medical device recall Z-1679-2022
Ongoing recall by Abbott Molecular, Inc., reported 2022-09-14, distributed in AZ, CA, CT, FL, GA, IL, KS, KY…. Reports received of an increase of message code 9186 (internal control failed) when using the kit.
| Recall number | Z-1679-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Molecular, Inc., Des Plaines, IL, United States |
| Recall initiated | 2022-08-19 |
| Classified | 2022-09-06 |
| Reported by FDA | 2022-09-14 |
| Distributed | AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, WI |
| Countries outside the US | CL, TW |
| Quantity | 579 kits |
| UPC / GTIN / UDI-DI | 00884999049208 |
| Lot numbers | 530738 |
| Model numbers | 09N78-085 |
Product
Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
Reason for recall
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
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-1679-2022. 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.