Helena Laboratories, Corp. recalls Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon)…
- Recall date
- May 23, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0537-2020
- FDA classification
- Class III
- Brand / firm
- Helena Laboratories, Corp.
- Sold / distributed
- US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan
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.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
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