Helena Laboratories Recalls Cascade Abrazo c-ACT-LR Test Cards
Helena Laboratories is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards due to reported variations in test results.
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 inaccurate diagnostic results (variations in timing) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Helena Laboratories, Inc. is recalling 27 kits of Cascade Abrazo c-ACT-LR Test Cards, Model/Catalog Number 5701, Lot Code 1-16-5701. The products are intended for in vitro diagnostic use and were distributed to four international distributors in Australia, the Netherlands, Italy, and England, with remaining products under the control of the manufacturer in Texas.
The recall was initiated because some cards in this lot were reported to have experienced variations in results, verified by wave form. These variations resulted in some cards displaying shorter or longer times than expected. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers and distributors should stop using the affected test cards and contact Helena Laboratories for further instructions or a refund.
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
- Manufacturer
- Helena Laboratories, Inc.
- Hazard
- Affected units
- 27
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: 1-16-5701 Model/Catalog Number: 5701
Distribution
Distributed in 1 state:
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