Helena Laboratories, Corp.: Medical Device Recall in 2020 - (Recall #: Z-0635-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 9, 2020

Date Posted: December 23, 2020

Recall Number: Z-0635-2021

Event ID: 86774

Reason for Recall:

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

Status: Ongoing

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated