Recall archive / FDA device enforcement
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 ... — FDA record Z-1679-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- Abbott Molecular, Inc.
- Quantity
- 579 kits
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1679-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #530738, UDI (01)00884999049208(10)530738(17)230527(240)09N78-085. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OK, PA, RI, TN, TX, WA, and WI. There was government distribution but no military distribution. Foreign distribution was made to Chile and Taiwan.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Sep 14, 2022
- Recall initiation date
- Aug 19, 2022
- Center classification date
- Sep 6, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.