Device product
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.
Z-0635-2021
Product summary
- Event
- Event 86774
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
- Official record key
device-enforcement:Z-0635-2021
Official wording
Reason: Due to complaints received associated with cracked/split test tube caps.
Code information: Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT
Distribution pattern: 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.
Derived failure modes
-
Unknown
Due to complaints received associated with cracked/split test tube caps.