FDA recall Z-0635-2021

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.

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.

Key facts

Status

Ongoing

Initiation date

2020-11-09

Report date

2020-12-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0635-2021