FDA-Device2018-12-12Class II
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
Helena Laboratories, Inc.
Hazard
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Sold states
US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England
Affected count
27 kits
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2019Don't want to check this manually?
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