Abbott recalls ARCHITECT BNP Calibrators due to stability drift causing inaccurate BNP test results. Affected units include specific lot numbers from July 2019 to January 2020. Consumers should contact Abbott for details.
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Abbott is recalling ARCHITECT BNP Calibrators because they can cause inaccurate blood test results over time. This affects laboratory equipment used for measuring BNP levels in patients. Using these calibrators without correction could lead to incorrect health diagnoses.
The calibrators can develop a time-dependent stability drift, meaning test results become less accurate over time. This drift causes patient and control results to shift, potentially leading to incorrect BNP measurements. The issue occurs in the calibration process for blood tests.
Laboratories using Abbott's ARCHITECT BNP Calibrators for blood tests are affected. Patients receiving results from these calibrators may be at risk of incorrect diagnoses.
Check for lot numbers listed in the recall: 44K79318 (23JUL2019), 44K80818 (05SEP2019), 44K82118 (09OCT2019), 44K82618 (15NOV2019), 44K85119 (22JAN2020), and 44K79418 (23JUL2019), 44K81018 (05SEP2019), 44K82018 (09OCT2019), 44K85219 (22JAN2020).
Look for the lot number on the calibrator label, which is listed in the recall for specific dates.
The ARCHITECT BNP Calibrators can develop a time-dependent stability drift, causing inaccurate blood test results over time.
Contact Abbott Laboratories for details on the specific lot numbers and next steps.
The recall is for potential inaccurate test results, not immediate safety risks. The danger level is low risk.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2078-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2078-2019 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.
