FDA Device recall Z-1108-2021
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
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of th… by Helena Laboratories, citing intermittent potential for shorter than expected clot times.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1108-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-05 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Helena Laboratories |
| Distribution | US |
Product
Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
Reason
Intermittent potential for shorter than expected clot times.
Identifiers
| code_info | Model Number: 5722 Lot Numbers: 1-20-5722 expiration date 90/30/2021; 3-20-5722 expiration date 11/30/2021; 4-20-5722 expiration date 12/31/2021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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 - 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 - Collagen Reagent, Cat
FDA Device · Class III · 2019-12-04 · 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-1108-2021%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.