FDA-Device2024-02-21Class II
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Microbiologics Inc
Hazard
The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for Norovirus when running the negative control.
Sold states
US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, MA, MI, MN, MO, MS, MT, NE, NH, NJ, NY, OH, PA, RI, TN, TX, VA, WA, WI, WV, and WY. There was government distribution and no military distribution. Foreign distribution was made to France.
Affected count
580 packages
Manufactured in
200 Cooper Ave N, N/A, Saint Cloud, MN, United States
Products
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1075-2024Don't want to check this manually?
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