Reported Dec 4, 2019 · Ongoing
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon)…
Helena Laboratories, Corp.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Helena Laboratories, Corp. · 1530 Lindbergh Dr · Beaumont, TX · 77707-4131
Is this the product you have?
- Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies
- ContainsCollagen (equine tendon) For In-Vitro Diagnostic Use
- Lot codes and dates
Component Lot # 5-17-5368 (Collagen)Exp. 5/31/19 Kit Lot # 3-17-5369
- Amount recalled
- 64 Aggregation Kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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