K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL… — Class II medical device recall Z-0635-2021
Ongoing recall by Helena Laboratories, Corp., reported 2020-12-23, distributed nationwide. Due to complaints received associated with cracked/split test tube caps.
| Recall number | Z-0635-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Helena Laboratories, Corp., Beaumont, TX, United States |
| Recall initiated | 2020-11-09 |
| Classified | 2020-12-17 |
| Reported by FDA | 2020-12-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, ES, FR, GB, IT, PT, RU |
| Reason classes | packaging |
| Lot numbers | 1-19-K-ACT, 2-19-K-ACT |
Product
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
Reason for recall
Due to complaints received associated with cracked/split test tube caps.
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-0635-2021. 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.