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

FDA device recall Z-1075-2024 · posted 2024-02-12 · Open, Classified

Recall details

Recalling firm

Microbiologics Inc

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.

Action taken

The recalling firm issued letters dated 1/8/2024 beginning 1/8/2024 informing the consignee of the issue and providing the following instructions: (1) Review lab procedures to understand how this information affects your usage; (2) Use or discard depending on your lab procedures and how this information affects your usage; (3) Complete the response form provided; (4) Return the response form to the firm; (5) keep the letter for your records; and (6) contact Microbiologics if a replacement kit is needed. On 1/25/2024, the firm issued letters dated 1/24/2024 via email to notify consignees they have expanded the recall to include additional lot numbers. Other than providing additional lot numbers, the letter was the same as the initial letter issued on 1/8/2024. The firm reported the email that had the letter attached alerted the consignee that the recall was expanded to include additional lot numbers.

Root cause

Process control

Status

Open, Classified

Product code

OHQ

Quantity affected

580 packages

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 govern

Date initiated

2024-01-08

Date posted

2024-02-12

Location

Saint Cloud, MN