FDA recall Z-0562-2021

Becton, Dickinson and Company, BD Biosciences · Class II · device

Product

BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.

Reason for recall

Recent product complaints showing an unexpected cell population exhibiting dim CD3 expression that may result in inaccurate results gating.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of AL, CA, CO, CT, DE, FL, GA, IL, IN, KY, MA, MD, MI, NC, NJ, NV, NY, OH, OK, PA, PR, RI, SD, TN, TX, and VA. The countries of Canada, Belgium, Korea, India, Ecuador, Japan, Costa Rica, Australia, Vietnam, Pakistan, Singapore, Thailand, and Peru.

Key facts

Status
Terminated
Initiation date
2020-10-05
Report date
2020-12-16
Termination date
2022-03-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0562-2021