Abbott Alinity m SARS-CoV-2 Control Kit Recall: Message Code 9186 Errors
Abbott recalls Alinity m SARS-CoV-2 Control Kits (REF 09N78-085) due to reported message code 9186 errors. Affected kits may show internal control failures during testing.
Lower-risk recall
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
Contact the company
What happened, in plain English
Abbott is recalling its Alinity m SARS-CoV-2 Control Kits (REF 09N78-085) because users have reported message code 9186 errors indicating internal control failures. This could lead to inaccurate test results if the kit is used without proper functioning. Read more at govinfonow.com/recall/60137-abbott-alinity-m-sars-cov-2-control-kit-recall-message.
Source Summary by GovInfoNow · govinfonow.com/recall/60137-abbott-alinity-m-sars-cov-2-control-kit-recall-message · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1679-2022
Cite this page
“Abbott Alinity m SARS-CoV-2 Control Kit Recall: Message Code 9186 Errors.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60137-abbott-alinity-m-sars-cov-2-control-kit-recall-message. Based on FDA recall #Z-1679-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1679-2022%22&limit=1).
Why it’s dangerous
The kit may show message code 9186 errors when internal controls fail, leading to inaccurate test results. This happens because the control components don't function properly during testing.
Who’s affected
People using Abbott Alinity m SARS-CoV-2 Control Kits (REF 09N78-085) for in vitro diagnostic testing are affected. Those performing tests with this specific kit version are most at risk of inaccurate results.
How to tell if you have this one
Check for the kit reference number 09N78-085 on the packaging. The kit contains 12 x 1.3mL CTRL - and 12 x 1.3mL CTRL + components for in vitro diagnostic use.
- Brand
Abbott- 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- Category
Medical device
What to do — step by step
Check Kit Reference
Verify the kit reference number 09N78-085 on the packaging to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed in 24 states, and outside the U.S.
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, Washington, Wisconsin.
Recall timeline
FDA published this recall 26 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1679-2022 (August 19, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1679-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.