Z-0635-2021Class II

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and...

Name: Z-0635-2021 K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and...
Creator: Helena Laboratories, Corp.
Published: 2020-11-09
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2020-11-09 / Open, Classified / root cause: manufacturing process

FDA source

Helena Laboratories, Corp. began a recall of 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 on 2020-11-09. FDA classified it as Class II and gives the reason as "Due to complaints received associated with cracked/split test tube caps". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0635-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-09
Posted: 2020-12-17
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.
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: Due to complaints received associated with cracked/split test tube caps.
Root cause tag: manufacturing process
FDA 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 [email protected] or 1-800-231-5663 extension 1177.
Quantity in commerce: 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.
Product codes and lots: Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0635-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0635-2021	Class II	Ongoing	Voluntary: Firm initiated	2020-12-23	2020-12-17

Product code JPA

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)