Cascade Abrazo aPTT Test Card — Class II medical device recall Z-2761-2019
Terminated recall by Helena Laboratories, Corp., reported 2019-10-09. Some of the cards show occasional shorter clot times than the expected variation resulting in a potential fals
| Recall number | Z-2761-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2017-12-07 |
| Classified | 2019-09-30 |
| Reported by FDA | 2019-10-09 |
| Terminated | 2020-06-09 |
| Countries outside the US | AU, DE |
| Quantity | 21 kits |
| Reason classes | potency |
| Lot numbers | 2-17-5722 |
| Model numbers | 5722 |
| Expiration dates | 2018-09-30 |
Product
Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
Reason for recall
Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay.
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-2761-2019. 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.