Helena Laboratories Recalls Collagen Reagent Due to Potential Contamination
Helena Laboratories is recalling Collagen Reagent kits because vials may contain particulate matter or microbial growth.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The hazard involves potential contamination in an in-vitro diagnostic reagent, fitting the criteria for a moderate, precautionary recall.
Plain-English summary
Helena Laboratories, Corp. is recalling 64 Aggregation Kits containing Collagen Reagent, Cat. No. 5368. The product is used for in-vitro platelet aggregation studies and contains collagen derived from equine tendon.
The recall was initiated after an investigation determined that vials of Collagen packaged within the kits may contain particulate matter or microbial growth. The affected component lot is # 5-17-5368 with an expiration date of 5/31/19, and the kit lot is # 3-17-5369.
The product was distributed in the United States to Texas, West Virginia, Ohio, Tennessee, Georgia, New York, Maine, Massachusetts, Louisiana, and Arizona. It was also distributed internationally to Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil, China, and Taiwan. Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
- Manufacturer
- Helena Laboratories, Corp.
- Affected units
- 64
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Component Lot # 5-17-5368 (Collagen)
- Exp. 5/31/19 Kit Lot # 3-17-5369
Distribution
Part of a larger recall action
This product is one of 2 recalled by Helena Laboratories, Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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