Abbott recalls ARCHITECT BNP Controls due to potential time-dependent stability drift in patient and control results, which may affect test accuracy for BNP measurements.
Presence of a time dependent, stability drift in patient and control results returned from ARCHITECT BNP testing.
Abbott is recalling ARCHITECT BNP Controls because they can cause time-dependent stability drift in test results, potentially leading to inaccurate BNP measurements. This affects laboratory testing for heart failure. Users should contact Abbott for details on affected lots.
The controls may show time-dependent stability drift, meaning test results for BNP (a heart failure marker) can become less accurate over time. This could lead to incorrect diagnoses or treatment decisions if not addressed.
Laboratories using Abbott's ARCHITECT BNP Controls for heart failure testing are affected. Those handling patient samples with these controls are at risk of inaccurate results.
Check the product label for lot numbers: 44K78918 (exp 18JUN2019), 44K80918 (exp 05SEP2019), 44K82718 (exp 15NOV2019), 44K79518 (exp 23JUL2019), 44K81118 (exp 05SEP2019), and 44K82818 (exp 15NOV2019).
Look for lot numbers on the label: 44K78918 (exp 18JUN2019), 44K80918 (exp 05SEP2019), 44K82718 (exp 15NOV2019), 44K79518 (exp 23JUL2019), 44K81118 (exp 05SEP2019), or 44K82818 (exp 15NOV2019).
The ARCHITECT BNP Controls are used for estimating test precision and detecting systematic analytical deviations in the ARCHITECT iSystem when measuring B-type natriuretic peptide (BNP) in human EDTA plasma.
Affected lots include 44K78918 (exp 18JUN2019), 44K80918 (exp 05SEP2019), 44K82718 (exp 15NOV2019), 44K79518 (exp 23JUL2019), 44K81118 (exp 05SEP2019), and 44K82818 (exp 15NOV2019).
The stability drift can cause time-dependent changes in test results, potentially leading to inaccurate BNP measurements and incorrect heart failure diagnoses.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-2079-2019 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-2079-2019 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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