Class II

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

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Microbiologics Inc Medical Device Recall: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. | SafeCheck