Class III — Helena Laboratories, Corp.
| Recalling firm | HELENA LABORATORIES, CORP. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | 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. |
| 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 DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3) |
| Quantity | 383 Collagen Kits |
| Distribution | US:TX, WV, OH, TN, GA, TN, NY, ME, MA,LA, AZ OUS: Israel, Korea, Australia, Indonesia, Canada, Thailand, Colombia, Brasil , China , Taiwan |
| Initiated | 2018-05-23 |
| Classified | 2019-11-22 |
| Recall number | Z-0536-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Helena Laboratories, Corp. (Z-0536-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/83930/
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