FDA Device recall Z-1075-2024
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184
- FDA Device
- Class II
- ongoing
- Published 2024-02-21
On 2024-02-21 the FDA classified a Class II recall of Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184 by Microbiologics, citing 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 neg….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1075-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-01-08 |
| Published | 2024-02-21 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microbiologics |
| Distribution | US |
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.
Identifiers
| code_info | Lot #8184-68, Exp. 5/31/2025, UDI-DI 70845357041448. UPDATE: The recall was expanded on 1/23/2024 to include the foll…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1075-2024%22
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