FDA Device recall Z-0594-2019
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The…
- FDA Device
- Class II
- terminated
- Published 2018-12-19
On 2018-12-19 the FDA classified a Class II recall of Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The… by Helena Laboratories, citing due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0594-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-20 |
| Published | 2018-12-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Helena Laboratories |
| Distribution | TX |
Product
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.
Reason
Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected
Identifiers
| code_info | Lot Codes: 1-15-5701 Model/Catalog Number: 5701 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0594-2019%22
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