Helena Laboratories recalls collagen reagent (Cat. No. 5368) for possible particulate matter or microbial growth in lab tests. Affected units may cause inaccurate results.
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 collagen reagent vials that could contain particles or microbes, which might lead to inaccurate lab test results. Users should stop using these products to avoid potential errors in platelet aggregation studies.
The collagen reagent may contain particles or microbes that could contaminate lab samples. This might cause inaccurate results in platelet aggregation tests, but does not pose a direct health risk to users.
Lab researchers and technicians using the collagen reagent for platelet aggregation studies are most at risk. The recall affects specific product lots manufactured between 2017 and 2019.
Check for product lot numbers 5-17-5368 (Collagen) or 3-17-5369 (Kit) on the vial. The reagent expires May 31, 2019, and is sold for in-vitro diagnostic use.
Look for lot numbers 5-17-5368 on the collagen vial or 3-17-5369 on the kit.
The recall states the product may contain particles or microbes that could cause inaccurate test results, but does not indicate a direct health risk.
The recall does not specify a remedy, so users should check the lot numbers and contact Helena Laboratories for further guidance.
Check for lot numbers 5-17-5368 (Collagen) or 3-17-5369 (Kit) on the vial. The product expires May 31, 2019.
We’ve drafted a message you can send Helena Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-0537-2020 — Helena Laboratories Helena Laboratories Hello, I own a Helena Laboratories that is covered by recall Z-0537-2020 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.
