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.
FDA Recall Z-0635-2021 · Posted None
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Recalling FirmHelena Laboratories, Corp.
Recall StatusOpen, Classified
Product CodeJPA
Date Initiated2020-11-09
Product QuantityLot 1-19-K-ACT = 314 tubes and Lot 2-19-K-ACT = 297 tubes
Reason for Recall
Due to complaints received associated with cracked/split test tube caps.
Firm 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 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 [email protected] or 1-800-231-5663 extension 1177.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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