Drug recall
K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and…
FDA recall event 86774 · Class II · Helena Laboratories, Corp.
Key facts
| Event ID | 86774 |
|---|---|
| Recall numbers | Z-0635-2021 |
| Recalling firm | Helena Laboratories, Corp. |
| Product type | Devices |
| Products | 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. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to complaints received associated with cracked/split test tube caps. |
| Initiation date | Nov 9, 2020 |
| Report date | Dec 23, 2020 |
| City | Beaumont |
| State | TX |
| Country | United States |
| FEI number | 1618982 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: