FDA Device recall Z-1679-2022
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
- FDA Device
- Class II
- ongoing
- Published 2022-09-14
On 2022-09-14 the FDA classified a Class II recall of 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 by Abbott Molecular, citing reports received of an increase of message code 9186 (internal control failed) when using the kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1679-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-19 |
| Published | 2022-09-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Molecular |
| Distribution | AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, WI |
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
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Identifiers
| code_info | Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1679-2022%22
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