Helena Laboratories Recalls Cascade Abrazo aPTT Test Cards for Clot Time Issues
Helena Laboratories is recalling Cascade Abrazo aPTT Test Cards due to intermittent potential for shorter than expected clot times.
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 with a defect that could lead to inaccurate test results (shorter clot times), posing a risk of harm to patients if used for clinical decisions, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Helena Laboratories, Corp. is recalling 205 kits of Cascade Abrazo aPTT Test Cards, Model 5722. These test cards are intended for use with the Cascade Abrazo analyzer to determine the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma. The affected lots are 1-20-5722, 3-20-5722, and 4-20-5722, with expiration dates ranging from September 30, 2021, to December 31, 2021.
The recall was initiated due to an intermittent potential for shorter than expected clot times. This defect could affect the accuracy of the aPTT results obtained from the test cards.
The product was distributed worldwide, including the United States, Germany, Italy, Romania, Australia, and Chile. Users of these test cards should stop using the affected lots and contact Helena Laboratories for further instructions.
The recalled product
- Product
- Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
- Manufacturer
- Helena Laboratories, Corp.
- Hazard
- Affected units
- 205
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 (3)
- Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021
- 3-20-5722 expiration date 11/30/2021
- 4-20-5722 expiration date 12/31/2021
Distribution
Distributed nationwide across the United States.
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