Reported Oct 9, 2019 · Terminated
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories,…
Helena Laboratories, Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Helena Laboratories, Corp. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Lot codes and dates
Lot number 2-17-5722Exp. 2018-09-30
- Amount recalled
- 21 kits
Why it was recalled
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
This product could cause temporary or reversible health problems — stop using it.
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