Recall Z-0635-2021 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
Helena Laboratories, Corp.
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.
| Date | Nov 9, 2020 |
| Status | Open, Classified |
| Reason | Due to complaints received associated with cracked/split test tube caps. |
| Root cause | Nonconforming Material/Component |
| Action | On 11/09/2020, international distributors were initially contacted and provided with a notification for distributors letter. On 11/16/2020 domestic customers were contacted via telephone and then a formal notification was delivered. The Recalling Firm was informing its customers to the potential of defect associated with the (flip-top) caps for some test tubes where the cap my split resulting in leaking of biohazardous fluids as users are instructed to shake the tube for proper mixing. Customers are instructed to immediately examine their inventory and quarantine affected product. If custo |
| Quantity | Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes |
| Distribution | Worldwide distribution - U.S. Nationwide including in the states of NJ, NY, PA and TX. The countries of Austria, Canada, England, France, Italy, Portugal, Russia, Spain. |
| FDA record | Open on fda.gov |