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.
- Company
- Helena Laboratories, Corp.
- Recall Initiated
- November 9, 2020
- Recall Number
- Z-0635-2021
- Quantity
- Lot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
- Firm Location
- Beaumont, TX
Reason for Recall
Due to complaints received associated with cracked/split test tube caps.
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.
Lot / Code Info
Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT
Root Cause
Nonconforming Material/Component
Action Taken
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 customers have further distributed the affected product, they are asked to identify the users within their facility to notify them at once of this product recall. Customers are also asked to complete and return the response form as soon as possible. For any questions, customer can email or call the Recalling Firm as jhanka@Helena.com or 1-800-231-5663 extension 1177.