Microbiologics Enteric Pathogens Control Panel — Class II medical device recall Z-1075-2024
Ongoing recall by Microbiologics Inc, reported 2024-02-21, distributed nationwide. The negative control was contaminated with one of the positive control pathogens (Norovirus). This would resul
| Recall number | Z-1075-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Microbiologics Inc, Saint Cloud, MN, United States |
| Recall initiated | 2024-01-08 |
| Classified | 2024-02-12 |
| Reported by FDA | 2024-02-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 580 packages |
| Reason classes | microbial contamination |
| Pathogens | norovirus |
| UPC / GTIN / UDI-DI | 70845357041448 |
| Lot numbers | 8184-65, 8184-66, 8184-67, 8184-68, 8184-69, 8184-70, 8184-71 |
| Model numbers | 8184 |
| Expiration dates | 2025-03-31, 2025-04-30, 2025-05-31, 2025-06-30, 2025-08-31 |
Product
Microbiologics Enteric Pathogens Control Panel (Inactivated Pellet), REF 8184.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1075-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.