Microbiologics Inc Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Brand
Microbiologics Inc
Lot Codes / Batch Numbers
Lot #8184-68, Exp. 5/31/2025, 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.
Products Sold
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.
Microbiologics Inc is recalling Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184. due to The negative control was contaminated with one of the positive control pathogens (Norovirus). This would result in users getting a positive call for . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026