Abbott recalls specific Afinion 2 analyzers (model #1116986) sold as moderate complexity due to incorrect configuration, which may cause inaccurate lab test results in CLIA waived labs.
Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could result in erroneous results.
Abbott is recalling certain Afinion 2 analyzers that were incorrectly labeled as moderate complexity. This could lead to inaccurate test results in labs that don't require full CLIA certification. Affected units were sold as refurbished in the U.S. with waived CLIA status.
The analyzers were incorrectly configured as moderate complexity devices instead of low complexity. This means labs that don't have full CLIA certification might run tests that could produce inaccurate results.
Labs with CLIA waived status that use the recalled Afinion 2 analyzers are most at risk. These are typically smaller labs without full laboratory certification.
Check for model #1116986, US refurbished, CLIA waived status. Affected units have serial numbers AF20008880, AF20002691, AF20035414, AF20015543, or AF20035460.
Verify the model number and serial numbers listed in the recall notice to confirm if your analyzer is affected.
The analyzers were incorrectly configured as moderate complexity devices, which could lead to inaccurate test results in labs with CLIA waived status.
Using these analyzers could result in erroneous test results, but does not pose a direct safety risk to users.
Check for model #1116986, US refurbished, CLIA waived status, and serial numbers AF20008880, AF20002691, AF20035414, AF20015543, or AF20035460.
We’ve drafted a message you can send Abbott Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2736-2024 — Abbott Diagnostics Abbott Diagnostics Hello, I own a Abbott Diagnostics that is covered by recall Z-2736-2024 from Abbott Diagnostics. 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.
