FDA-Device2022-03-09Class II

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

Microbiologics Inc
Hazard

Real-time shelf life testing failed at 24 months

Sold states
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.
Affected count
29 units
Manufactured in
200 Cooper Ave N, Saint Cloud, MN, United States
Products
Microbiologics QC Sets and Panels. BD MAX" CT/GC/TV Verification and Control Panel. Containing High, Medium and Low Level Controls.

Official notice

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

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