Abbott recalls HbA1c calibrators that may have incorrect manufacturing, risking inaccurate blood sugar test results outside a specific concentration range. Affected units may need replacement to ensure accurate diabetes monitoring.
Calibrator level 2 bottle may have been manufactured incorrectly for a portion of the lot. The manufacturer observed no impact to assay performance between the HbA1c concentration range of 5.33% to 6.87%. However, outside of this range, a bias of greater than 3% may be seen with patient results. The device failure that is associated with this recall can result in potentially negatively and positively biased patient test results for HbA1c. The firm is investigating the root cause.
Abbott is recalling HbA:1c calibrators that could produce inaccurate blood sugar test results for some patients. This affects people using these calibrators with their diabetes testing devices, potentially leading to incorrect health decisions.
The calibrator level 2 bottle may have been made incorrectly for part of a production lot. This can cause test results to be too high or too low outside a specific blood sugar concentration range (5.33% to 6.87%). The manufacturer says this doesn't affect results within that range but could cause errors outside it.
People using Abbott's HbA1c calibrators with their diabetes testing devices are affected. Those with diabetes who rely on these calibrators for accurate blood sugar monitoring are most at risk.
Check for the model number 4P52-01 and lot number 54582UQ02 on the calibrator bottle. These calibrators are used with Abbott's Architect diabetes testing devices.
Look for the model number 4P52-01 and lot number 54582UQ02 on the calibrator bottle.
No, the recall states the calibrator may cause inaccurate test results but not direct injury.
Check for the model number 4P52-01 and lot number 54582UQ02 on the calibrator bottle.
The recall does not specify a remedy, so contact Abbott directly for guidance.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-1688-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-1688-2020 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.
