Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE… — Class II medical device recall Z-0561-2019
Terminated recall by Helena Laboratories, Inc., reported 2018-12-12, distributed in TX. Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), res
| Recall number | Z-0561-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Inc., Beaumont, TX, United States |
| Recall initiated | 2017-02-24 |
| Classified | 2018-12-06 |
| Reported by FDA | 2018-12-12 |
| Terminated | 2023-10-20 |
| Distributed | TX |
| Countries outside the US | AU, GB, IT, NL |
| Quantity | 27 kits |
| Lot numbers | 1-16-5701 |
| Model numbers | 5701 |
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
Reason for recall
Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0561-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.