Cascade Abrazo aPTT Test Card — Class II medical device recall Z-1108-2021
Terminated recall by Helena Laboratories, Corp., reported 2021-02-17, distributed nationwide. Intermittent potential for shorter than expected clot times.
| Recall number | Z-1108-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2021-01-05 |
| Classified | 2021-02-11 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2024-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CL, DE, IT, RO |
| Quantity | 205 kits |
| Lot numbers | 1-20-5722, 3-20-5722, 4-20-5722 |
| Model numbers | 5722 |
| Expiration dates | 2021-11-30, 2021-12-31 |
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 for recall
Intermittent potential for shorter than expected clot times.
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-1108-2021. 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.