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U.S. Department of Health and Human Services

Class 2 Device Recall Microbiologics

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 Class 2 Device Recall Microbiologicssee related information
Date Initiated by FirmJanuary 08, 2024
Date PostedFebruary 12, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1075-2024
Recall Event ID 93801
Product Classification Multi-analyte controls unassayed - Product Code OHQ
ProductMicrobiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
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.
FEI Number 2150138
Recalling Firm/
Manufacturer		 Microbiologics Inc
200 Cooper Ave N
Saint Cloud MN 56303-4440
For Additional Information ContactRebecca Neu
320-229-7080
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionThe 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.
Quantity in Commerce580 packages
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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