Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Export
Helena Laboratories is recalling 21 kits of Cascade Abrazo aPTT Test Cards, Model 5722, distributed to Germany and Australia, due to potential false negative 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that may produce false negative results on a screening assay, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Helena Laboratories, Corp. is recalling 21 kits of the Cascade Abrazo aPTT Test Card, Model 5722. The product is labeled for export only, and the firm name on the label is Helena Laboratories, Beaumont, TX. The specific lot number is 2-17-5722, with an expiration date of September 30, 2018.
The recall was initiated because some of the test cards show occasional shorter clot times than expected. This variation can result in a potential false negative result on the screening assay. The agency has classified this recall as Class II.
Distribution was made to Germany and Australia. There was no U.S. distribution of these products. Consumers or healthcare providers in the affected countries should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
- Manufacturer
- Helena Laboratories, Corp.
- Hazard
- Affected units
- 21
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 (2)
- Lot number 2-17-5722
- Exp. 2018-09-30
Distribution
Distribution scope not specified by the agency.
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