Helena Laboratories, Corp. recalls K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MIN…
- Recall date
- November 9, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0635-2021
- FDA classification
- Class II
- Brand / firm
- Helena Laboratories, Corp.
- Sold / distributed
- 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.
Why it was recalled
Due to complaints received associated with cracked/split test tube caps.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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