FDA recall Z-0698-2022

Product

Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.

Reason for recall

Real-time shelf life testing failed at 24 months

Distribution

Worldwide distribution - US Nationwide distribution in the states of AK, CA, DC, FL, IA, ID, KS, LA, MD, MN, MO, NE, NH, NJ, NY, OH, OK, PA, SC, TX, VA, WA, WV and the countries of Australia, Belgium, Canada, India, United Kingdom.

Key facts

Status

Terminated

Initiation date

2017-06-06

Report date

2022-03-09

Termination date

2023-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Saint Cloud, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0698-2022