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Recall Observatory FDA recall evidence

Device product

Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.

Z-1075-2024

January 08, 2024

Class II

Product summary

Firm
Microbiologics Inc
Event
Event 93801
Status
Ongoing
Classification
Class II
Quantity
580 packages
Official record key
device-enforcement:Z-1075-2024

Official wording

Reason: 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.

Code information: Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448. UPDATE: The recall was expanded on 1/23/2024 to include the following additional lot numbers: 8184-65, exp. 3/31/2025; 8184-66, exp. 4/30/2025; 8184-67, exp. 5/31/2025; 8184-69, exp. 6/30/2025; 8184-70, exp. 8/31/2025; and 8184-71, exp. 8/31/2025.

Distribution pattern: 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.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    contaminated with one of the positive control pathogens (Norovirus