FDA Device recall Z-0635-2021
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING…
- FDA Device
- Class II
- ongoing
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING… by Helena Laboratories, citing due to complaints received associated with cracked/split test tube caps.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0635-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-11-09 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Helena Laboratories |
| Distribution | US |
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
Due to complaints received associated with cracked/split test tube caps.
Identifiers
| code_info | Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
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All Helena Laboratories recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0635-2021%22
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