FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0635-2021
- Recalling firm
- Helena Laboratories, Corp.
- 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.
- Status
- Open, Classified
- Initiated
- 2020-11-09
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- 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.
- Lot, serial or model codes
- Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT
- 510(k) numbers
- ["K013078","K061014"]
- PMA numbers
- not on file
- Product code
- JPA
- Firm FEI
- 1618982
- Firm city
- Beaumont
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28