Helena Laboratories recalls export-only Cascade Abrazo aPTT Test Card Model 5722 due to potential false negatives from shorter clot times. Affected units sold with lot 2-17-5722 expiring 2018-09-30.
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
Helena Laboratories is recalling export-only Cascade Abrazo aPTT Test Card Model 5722 because some cards may show shorter clot times than expected, causing false negative results in screening tests. This could lead to incorrect health assessments if used without proper follow-up.
The test cards may produce shorter clot times than expected, which can cause false negative results in screening assays. This means the test might incorrectly indicate that a blood sample is safe when it isn't, potentially leading to missed health issues.
Users of the export-only Cascade Abrazo aPTT Test Card Model 5722 for international medical testing. Those with the specific lot number 2-17-5722 are most at risk of false negative results.
Check for the model number 5722 on the label. The product was sold for export only with lot number 2-17-5722, expiring September 30, 2018.
Look for the model number 5722 and lot number 2-17-5722 on the label.
The product may cause false negative results in screening assays, so it's not recommended for use without verification.
The recall record does not specify a remedy, so check the label for the model number and lot number to confirm if it's affected.
Check for the model number 5722 and lot number 2-17-5722 on the label, as this product was sold for export only with an expiration date of September 30, 2018.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-2761-2019 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-2761-2019 from Helena Laboratories. 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.
