Home / Recalls / Helena Laboratories, Corp. / Z-0537-2020

Z-0537-2020 Class III Ongoing

Recalled by Helena Laboratories, Corp. — Beaumont, TX

FDA device recall Z-0537-2020 was initiated by Helena Laboratories, Corp. on May 23, 2018 and is designated Class III. 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. The recall status is ongoing. Affected quantity: 64 Aggregation Kits.

Recall Details

Product Type
Devices
Report Date
December 4, 2019
Initiation Date
May 23, 2018
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64 Aggregation Kits

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,

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.

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

Code Information

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

Other recalls by Helena Laboratories, Corp.

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  • Z-1108-2021 Class II — Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade A (January 5, 2021)
  • Z-0635-2021 Class II — K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED C (November 9, 2020)
  • Z-1950-2019 Class II — ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. (August 8, 2018)
  • Z-1949-2019 Class II — ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use (August 8, 2018)
  • Z-0536-2020 Class III — Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, (May 23, 2018)
  • Z-0297-2020 Class III — SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and (February 27, 2018)
  • Z-2761-2019 Class II — Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on th (December 7, 2017)
  • Z-0045-2020 Class II — SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The f (July 21, 2017)

FDA data resources