Medical Device Recall: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Microbiologics Inc · January 8, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
580 packages
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1075-2024
Status: ongoing
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