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.
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
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.
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.
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.
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.
Verify the kit reference number 09N78-085 on the packaging to confirm if it is affected.
Abbott reports increased message code 9186 errors indicating internal control failures when using this specific kit version.
The official recall notice does not specify a remedy or action for affected kits.
Check for the reference number 09N78-085 on the packaging; the kit contains 12 x 1.3mL CTRL - and 12 x 1.3mL CTRL + components.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1679-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1679-2022 from Abbott. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
