Z-1075-2024Class II

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

Name: Z-1075-2024 Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184
Creator: Microbiologics Inc
Published: 2024-01-08
License: https://open.fda.gov/license/

Microbiologics, Inc. / initiated 2024-01-08 / Open, Classified / root cause: manufacturing process

FDA source

Microbiologics Inc began a recall of Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184 on 2024-01-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1075-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-08
Posted: 2024-02-12
Recalling firm: Microbiologics, Inc.
Product: Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Product code: OHQ Multi-Analyte Controls Unassayed
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1075-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1075-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-12

Product code OHQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)