Drug recall
Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366…
FDA recall event 81356 · Class II · Helena Laboratories, Inc.
Key facts
| Event ID | 81356 |
|---|---|
| Recall numbers | Z-0594-2019 |
| Recalling firm | Helena Laboratories, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected |
| Initiation date | Apr 20, 2016 |
| Report date | Dec 19, 2018 |
| Termination date | Feb 15, 2024 |
| City | Beaumont |
| State | TX |
| Country | United States |
| FEI number | 1618982 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: