FDAClass IIDecember 23, 2020

K-ACT Actalyke Clotting Test Tubes that are used in recall

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

Why was K-ACT Actalyke Clotting Test Tubes that are used in recalled?

Due to complaints received associated with cracked/split test tube caps.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Catalog Number: K-ACT Lot Number: 1-19-K-ACT and 2-19-K-ACT

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…
Recalling firm
Helena Laboratories, Corp.
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.
Recall date
December 23, 2020
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls