Abbott recalls ARCHITECT HAVAB-G Calibrator lot 08219BE00 due to potential false non-reactive results in patient testing. Affected units may show incorrect results between 0.50-0.99 S/CO.
Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control values and patient results. Patient values generated using the impacted calibrator lot 08219BE00 may have changed interpretation from reactive to falsely non reactive. Results impacted may present as a (falsely) non reactive result that fall in the range between 0.50 to 0.99 S/CO.
Abbott is recalling a specific lot of ARCHITECT HAVAB-G Calibrators because they might give false non-reactive results in patient testing. This could lead to incorrect interpretations of test results, particularly for values between 0.50 and 0.99 S/CO.
The calibrator lot 08219BE00 may produce higher Relative Light Units (RLUs) up to 94%, which can cause test results to show as falsely non-reactive instead of reactive. This affects results in the 0.50 to 0.99 S/CO range, potentially leading to misinterpretation of patient data.
Lab users who purchased the ARCHITECT HAVAB-G Calibrator with lot number 08219BE00 are affected. Patients using this calibrator for testing may experience incorrect results.
Check for the calibrator model ARCHITECT HAVAB-G with reference number 6L27-01 and lot number 08219BE00. This specific lot was identified as potentially impacted by the RLU increase.
Identify the lot number on your ARCHITECT HAVAB-G Calibrator to see if it matches 08219BE00.
Abbott identified that calibrator lot 08219BE00 may produce higher Relative Light Units (RLUs) up to 94%, causing test results to show as falsely non-reactive instead of reactive.
Results in the 0.50 to 0.99 S/CO range may be misinterpreted as non-reactive when they should be reactive, potentially affecting test accuracy.
Check the lot number on your ARCHITECT HAVAB-G Calibrator; if it is 08219BE00, it is affected.
We’ve drafted a message you can send Abbott to request your refund or repair — edit it as you like.
Subject: Recall Z-0574-2020 — Abbott Abbott Hello, I own a Abbott that is covered by recall Z-0574-2020 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.
