FDA Medical Device Recalls (openFDA)
Microbiologics Inc: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
- Recall number
- Z-1075-2024
- Recalling firm
- Microbiologics Inc
- Product
- Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
- Status
- Open, Classified
- Initiated
- 2024-01-08
- Posted
- 2024-02-12
- Terminated
- not on file
- 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.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 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 government distribution and no military distribution. Foreign distribution was made to France.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OHQ
- Firm FEI
- 2150138
- Firm city
- Saint Cloud
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28