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.
Other recalls by Helena Laboratories
- Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitr…
FDA Device · Class II · 2023-06-28 · Helena Laboratories - V8 Immunodisplacement Kit REF 1803
FDA Device · Class II · 2022-06-15 · Helena Laboratories - Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th…
FDA Device · Class II · 2021-02-17 · Helena Laboratories - K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
FDA Device · Class II · 2020-12-23 · Helena Laboratories - Platelet Aggregation Kit, Cat
FDA Device · Class III · 2019-12-04 · Helena Laboratories
All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0537-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.