FDA recall Z-0561-2019

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

Reason for recall

Due to some cards in this lot reported to have experienced variations in results, (verified by wave form), resulting in some cards with shorter or longer times than expected.

Distribution

US: Products under control of Manufacturer in TX OUS: Four International Distributors - Australia, Netherlands, Italy, and England

Key facts

Status: Terminated
Initiation date: 2017-02-24
Report date: 2018-12-12
Termination date: 2023-10-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Beaumont, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2019