Reported Dec 19, 2018 · Terminated
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2)…
Helena Laboratories, Inc.
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, Inc. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
- Lot codes and dates
- Lot Codes1-15-5701
- Model/Catalog Number5701
- Amount recalled
- 12 Kits
Where it was sold
Why it was recalled
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
This product could cause temporary or reversible health problems — stop using it.
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