Collagen Reagent — Class III medical device recall Z-0537-2020
Ongoing recall by Helena Laboratories, Corp., reported 2019-12-04, distributed in AZ, GA, LA, MA, ME, NY, OH, TN…. Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent a
| Recall number | Z-0537-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2018-05-23 |
| Classified | 2019-11-22 |
| Reported by FDA | 2019-12-04 |
| Distributed | AZ, GA, LA, MA, ME, NY, OH, TN, TX, WV |
| Countries outside the US | AU, CA, CN, CO, ID, IL, KR, TH, TW |
| Quantity | 64 aggregation |
| Reason classes | microbial contamination, specification failure |
| Lot numbers | 3-17-5369, 5-17-5368 |
| Model numbers | 5368 |
| Expiration dates | 2019-05-31 |
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,
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0537-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.