Lower riskMedical device recall · FDA · Published May 23, 2018
Helena Laboratories Platelet Aggregation Kit Recall: Risk of Contaminated Reagents
Helena Laboratories recalls Platelet Aggregation Kit Cat. No. 5369 due to potential particulate matter or microbial growth in collagen vials. Affected units may pose contamination risks during lab studies.
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.
Take action
Contact the company
📍Recalling firmHelena Laboratories, Corp.1530 Lindbergh Dr · Beaumont, TX 77707-4131
“Helena Laboratories Platelet Aggregation Kit Recall: Risk of Contaminated Reagents.” GovInfoNow, updated August 21, 2026. https://govinfonow.com/recall/70993-helena-laboratories-platelet-aggregation-kit-recall-risk-of-contaminated-reagents. Based on FDA recall #Z-0536-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0536-2020%22&limit=1).
The FDA announced on May 23, 2018, that Helena Laboratories, Corp. voluntarily recalled Platelet Aggregation Kits due to potential particulate matter or microbial growth in Collagen vials. The agency issued recall number Z-0536-2020 for the Class III device.
How to tell if you have it
Brand: Helena Laboratories
Product: Platelet Aggregation Kit, Cat. No.5369
Component Lot #: 5-17-5368 (Collagen)
Kit Lot #: 3-17-5369
Kit Lot #: 5-17-5368
The hazard
The recall addresses vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit that may contain particulate matter or microbial growth. The FDA stated this issue was determined through an investigation.
Context
GovInfoNow's records show Helena Laboratories, Corp. has 8 other recalls on record since July 21, 2017. Other recent recalls of similar products include Instrumentation Laboratory Coagulation Test Kits Risk Microbial Contamination (Dec. 11, 2025), Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026), and Beckman Coulter DxH Diluent Recall: Elevated Platelet Counts Risk (Nov. 10, 2025).
How to tell if you have this one
Check for kit lot numbers 3-17-5369 (exp. 11/30/18) or 5-17-5368 (exp. 05/31/2019) with the product code Cat. No. 5369. The kit contains collagen from equine tendon and is for in-vitro diagnostic use.
Brand
Helena Laboratories
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Ongoing
Distribution
US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan
Recall number
Product, codes & lots
Quantity
Z-0536-2020
Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3); Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 (Aggregation kit containing Collagen), Exp. 11/30/18 Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019
383 Collagen Kits
Z-0537-2020
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,; Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369
64 Aggregation Kits
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Numbers
Identify kit lot numbers 3-17-5369 (exp. 11/30/18) or 5-17-5368 (exp. 05/31/2019) to confirm if affected.
Where it went and when
Where it was distributed
Distributed in 10 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Georgia, Louisiana, Maine, Massachusetts, New York, Ohio, Tennessee, Texas, West Virginia.
Recall timeline
FDA published this recall 18 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0536-2020 (May 23, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0536-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.