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.
Helena Laboratories is recalling a platelet aggregation kit that may contain particulate matter or microbial growth in collagen vials. This could contaminate lab samples during studies, though the risk is not immediate for end users.
The collagen vials in the kit may have particulate matter or microbial growth, which could contaminate lab samples during platelet aggregation studies. This poses a risk to sample integrity but not immediate harm to users.
Researchers and lab technicians using the kit for in-vitro diagnostic studies. Those handling the kit without proper quality checks are most at risk.
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.
Identify kit lot numbers 3-17-5369 (exp. 11/30/18) or 5-17-5368 (exp. 05/31/2019) to confirm if affected.
The recall indicates potential contamination risks, so it is not recommended for use until the manufacturer confirms the issue is resolved.
The official recall does not specify a remedy, so contact Helena Laboratories directly for guidance.
Check for kit lot numbers 3-17-5369 (exp. 11/30/18) or 5-17-5368 (exp. 05/31/2019) with product code Cat. No. 5369.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0536-2020 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-0536-2020 from Helena Laboratories. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
