# FDA recall Z-1679-2022

> **Abbott Molecular, Inc.** · Class II · device recall initiated 2022-08-19.

## 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.

## 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.

## Key facts

- **Recall number:** Z-1679-2022
- **Recalling firm:** Abbott Molecular, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-19
- **Report date:** 2022-09-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Des Plaines, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1679-2022

## Citation

> AI Analytics. FDA recall Z-1679-2022. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1679-2022. Source: US FDA. Licensed CC0.

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