Verigene CDF Nucleic Acid Test — Class II medical device recall Z-1334-2022
Ongoing recall by Luminex Corporation, reported 2022-07-13, distributed nationwide. There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP K
| Recall number | Z-1334-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2022-06-17 |
| Classified | 2022-07-06 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, FR, GR, KW, TR |
| Quantity | 296 units |
| UPC / GTIN / UDI-DI | 00840487101735 |
| Lot numbers | 042021022D, 071321022F, 100421022A, 110221022E, 2032870, 2100856, 2107946, 2110850 |
| Model numbers | 30-002-22 |
Product
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
Reason for recall
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.
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-1334-2022. 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.