Helena Laboratories, Corp.: Medical Device Recall in 2019 - (Recall #: Z-0537-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,

Product Classification:

Class III

Date Initiated: May 23, 2018

Date Posted: December 4, 2019

Recall Number: Z-0537-2020

Event ID: 83930

Reason for Recall:

Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.

Status: Ongoing

Product Quantity: 64 Aggregation Kits

Code Information:

Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369

Distribution Pattern:

US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan

Voluntary or Mandated:

Voluntary: Firm initiated