FDA Device recall Z-0537-2020
Collagen Reagent, Cat
- FDA Device
- Class III
- ongoing
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class III recall of Collagen Reagent, Cat by Helena Laboratories, citing 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 microb….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0537-2020 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2018-05-23 |
| Published | 2019-12-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| Distribution | AZ, GA, LA, MA, ME, NY, OH, TN, TX, WV |
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
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.
Identifiers
| code_info | Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2020%22
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