Recall Z-1075-2024— Microbiologics Inc
Class II · Ongoing
Class II FDA medical device recall by Microbiologics Inc, initiated 2024-01-08. FDA's recall record names no specific 510(k) clearance for this event. Product: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.. 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..
- Recalling firm
- Microbiologics Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-08
- Firm location
- Saint Cloud, MN, United States
Product description
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.