FDA-Device2020-12-23Class II
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Helena Laboratories, Corp.
Hazard
Due to complaints received associated with cracked/split test tube caps.
Sold states
Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain.
Affected count
Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
Manufactured in
1530 Lindbergh Dr, N/A, Beaumont, TX, United States
Products
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2021Don't want to check this manually?
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