Recall Z-2761-2019
Helena Laboratories, Corp. · initiated December 7, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Codes / lots: Lot number 2-17-5722, Exp. 2018-09-30
Reason for recall
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
FDA-determined cause: Unknown/Undetermined by firm
Action taken
The recalling firm issued letters dated 11/12/2017 via email on 12/7/2017 explaining the issue and that they were doing a withdrawal of the lot.
Details
- Recall number
- Z-2761-2019
- Initiated
- December 7, 2017
- Posted by FDA
- September 27, 2019
- Terminated
- June 9, 2020
- Product code
- GFO – Activated Partial Thromboplastin
- Quantity
- 21 kits
- Distribution
- Distribution was made to Germany and Australia. There was no U.S. distribution.
- Recalling firm
- Helena Laboratories, Corp., Beaumont, TX