Abbott recalls Alinity m System devices with potential calibration errors that could misconfigure testing results. Affected units may need recalibration or correction.
The firm identified the following three potential issues which may have impacted ADUs installed on distributed Alinity m Systems. 1. Systems which had their ADUs serviced may have an incorrect board value (calibration data file) referenced causing a misconfiguration of the calibration. 2. Inability of Maintenance and Diagnostics 2300 (Amp Detect Optical Calibrations) to recognize error handling and thermal hold errors during the calibration process, potentially leading to a misconfiguration of the calibration. 3. Under specific conditions during the ADU manufacturing process, an incorrect calibration may potentially have been configured.
Abbott is recalling Alinity m System devices that may have calibration errors causing misconfigured testing results. This could lead to inaccurate nucleic acid test outcomes if the system is used without correction.
The system may have incorrect calibration data causing misconfiguration of test results. This could happen if the device was serviced improperly or during manufacturing. The issue might lead to inaccurate nucleic acid testing outcomes.
Users of the Alinity m System for nucleic acid testing may be affected if their device has calibration issues. Laboratory staff handling these systems are most at risk of inaccurate test results.
Check for model number 08N53-002 on the Alinity m System. The recall applies to devices sold with this specific model number.
Verify if the system has been serviced or if calibration errors were detected.
Abbott identified potential calibration errors that could misconfigure test results in Alinity m System devices.
Check for model number 08N53-002 on the Alinity m System.
The recall does not specify a remedy, so contact Abbott for guidance on potential corrections.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1009-2023 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1009-2023 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.
