CLASS II ONGOING Device recall · Reported 21 Feb 2024 · FDA Enforcement Report
Enteric Pathogens Control Panel (Inactivated Pellet) recalled
Microbiologics is recalling Enteric Pathogens Control Panel (Inactivated Pellet), distributed nationwide in the US. The recall was initiated on 8 Jan 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1075-2024
- FDA event ID
- 93801
- Recalling firm
- Microbiologics, Saint Cloud, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jan 2024
- FDA classified
- 12 Feb 2024
- Reported
- 21 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Norovirus
- Device type
- Other Medical Devices
Timeline
| 8 Jan 2024 | Recall initiated by company | |
| 12 Feb 2024 | Classified by FDA | +35 days |
| 21 Feb 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
Where it was distributed
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.
Nationwide AlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyMassachusettsMichiganMinnesotaMissouriMississippiMontana
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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