FDA recall Z-0594-2019

Helena Laboratories, Inc. · Class II · device

Product

Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC USE Store at 2 to 8 C HELENA LABORATORIES 003366 12/13(2) FOR EXPORT ONLY The Cascade Abrazo c-ACT-LR test cards are activated clotting time tests to be used with the Cascade Abrazo analyzer and are intended to monitor the effect of low to moderate heparin on coagulation in fresh whole blood.

Reason for recall

Due to some cards in this lot experiencing variations in wave form, resulting in some cards with shorter or longer times than expected

Distribution

US Distribution to state of TX and internationally to: Australia, Netherlands, Italy, and England.

Key facts

Status
Terminated
Initiation date
2016-04-20
Report date
2018-12-19
Termination date
2024-02-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0594-2019