Abbott recalls Alinity m System with specific serial numbers due to potential for incorrect results after calibration. Affected units may need recalibration to ensure accurate test results.
The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.
Abbott is recalling a specific model of Alinity m System that may produce incorrect test results if not properly calibrated. This could lead to delayed or inaccurate medical test outcomes.
The instrument was installed without necessary plunger assemblies in the clamp bar for the Amplification Detection Unit. After correction, the instrument was returned for use without calibration, which could cause delays or incorrect test results.
Healthcare facilities using the recalled Alinity m System model with specific serial numbers are most at risk. Patients relying on accurate test results from this equipment could be affected.
Check for the Alinity m System with serial number 01015 and UDI code (01)00884999048034(11)220505(21)01015(240)08N53-002. The Amplification Detection Unit (ADU) #4 with serial number AMP05139 is also part of the recall.
Verify if the instrument has been recalibrated after the issue was corrected.
The instrument was found to be installed without plunger assemblies in the clamp bar for the Amplification Detection Unit, which could lead to delays or incorrect test results after recalibration.
Check if your Alinity m System has the specific serial number 01015 and UDI code (01)00884999048034(11)220505(21)01015(240)08N53-002. If so, ensure it has been recalibrated after correction.
The recall addresses potential for incorrect test results, not physical injury. The hazard does not involve immediate safety risks.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1349-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1349-2023 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.
