Helena Laboratories, Corp. recalls K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI

Recalled December 23, 2020 · FDA recall Z-0635-2021 · Helena Laboratories

Hazard

Due to complaints received associated with cracked/split test tube caps. · FDA Class II

Units

Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes

Sold at

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.

Description

Due to complaints received associated with cracked/split test tube caps.

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.

Manufacturer(s)

Helena Laboratories, Corp.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →