Helena Laboratories Recalls Platelet Aggregation Kits Due to Contamination
Helena Laboratories is recalling Platelet Aggregation Kits because the Collagen Reagent vials may contain particulate matter or microbial growth.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential microbial growth) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Helena Laboratories, Corp. is recalling 383 units of the Platelet Aggregation Kit, Catalog No. 5369. The recall is due to an investigation that determined vials of Collagen packaged within the Collagen Reagent and the Platelet Aggregation Kit may contain particulate matter or microbial growth.
The affected products include specific lots of the Aggregation Kit containing Collagen. The distribution pattern indicates the products were shipped to various US states and international locations, including Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil, China, and Taiwan.
Consumers and healthcare facilities should stop using the affected kits and contact Helena Laboratories for further instructions or a return. The products are intended for in-vitro diagnostic use in platelet aggregation studies.
The recalled product
- Product
- 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 DIAGNO
- Manufacturer
- Helena Laboratories, Corp.
- Affected units
- 383
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 (4)
- 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
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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