Class II — Luminex Corporation
| Recalling firm | Luminex Corporation |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab. |
| Product | VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23 |
| Quantity | 5601 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey. |
| Initiated | 2022-06-17 |
| Classified | 2022-07-06 |
| Recall number | Z-1335-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Luminex Corporation (Z-1335-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90122/
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