Abbott recalls ARCHITECT STAT Myoglobin Calibrators (RES 2K4:01) due to potential calibration errors. Controls may exceed specified ranges if used with this lot, affecting test accuracy.
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
Abbott is recalling specific ARCHITECT STAT Myoglobin Calibrators (RES 2K43-01) because they may cause calibration errors. This could lead to inaccurate test results if used in the ARCHITECT iSystem.
The calibrator lot failed stability testing, meaning it may not perform correctly over time. When used in calibration, it could cause test results to fall outside the acceptable range, leading to inaccurate myoglobin measurements.
Healthcare facilities using the ARCHITECT STAT Myoglobin Calibrators for myoglobin testing are most at risk. Patients receiving inaccurate test results could be affected.
Check for the model RES 2K43-01 on the calibrator. The recall applies to products sold with the UDI (Unique Device Identification) code (01)00380740003272(17)220531(10)166000.
Review test results to ensure they fall within the specified range as per the Instructions for Use.
The calibrator lot did not meet stability testing criteria, which could cause test results to exceed the specified range.
Look for the model RES 2K43-01 and the UDI code (01)00380740003272(17)220531(10)166000 on the calibrator.
The recall does not specify a remedy, so check calibration results and contact Abbott for further guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0891-2022 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0891-2022 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.
