FDA Device recall Z-0536-2020
Platelet Aggregation Kit, Cat
- FDA Device
- Class III
- ongoing
- Published 2019-12-04
On 2019-12-04 the FDA classified a Class III recall of Platelet Aggregation Kit, 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 microbi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0536-2020 |
| 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
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)
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 (Aggregation kit containing Collagen), Exp. 11…Component Lot # 5-17-5368 (Collagen), Exp. 5/31/19 Kit Lot # 3-17-5369 (Aggregation kit containing Collagen), Exp. 11/30/18 Kit Lot # 5-17-5368 (Aggregation Kit containing Collagen), Exp. 05/31/2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0536-2020%22
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