Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards
Helena Laboratories is recalling Cascade Abrazo c-ACT-LR test cards due to waveform variations that may result in inaccurate clotting time measurements.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic inaccuracy due to waveform variations, but no specific injuries, illnesses, or deaths are reported in the source text.
Plain-English summary
Helena Laboratories, Inc. is recalling 12 kits of Cascade Abrazo c-ACT-LR Test Cards, Lot 1-15-5701, Model/Catalog Number 5701. These in vitro diagnostic test cards are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood when used with the Cascade Abrazo analyzer.
The recall was initiated because some cards in this lot experienced variations in wave form, resulting in some cards with shorter or longer times than expected. This defect may lead to inaccurate activated clotting time results.
The affected products were distributed in the United States to the state of Texas and internationally to Australia, the Netherlands, Italy, and England. Users of these test cards should stop using the affected lot and contact Helena Laboratories for further instructions or a replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Helena Laboratories, Inc.
- Hazard
- Affected units
- 12
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Codes: 1-15-5701 Model/Catalog Number: 5701
Distribution
Distributed in 1 state:
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