Verigene EP Amplification Reagent Kit Test — Class II medical device recall Z-2451-2021
Ongoing recall by Luminex Corporation, reported 2021-09-22, distributed nationwide. There is potential for false positive results.
| Recall number | Z-2451-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2021-08-03 |
| Classified | 2021-09-10 |
| Reported by FDA | 2021-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, FR, GR, JP, TR |
| Quantity | 4,579 kits |
| Lot numbers | 010421023A, 010621023D, 010721023E, 011121023A, 011221023D, 011821023A, 011921023D, 012521023A, 012821023D, 020921023D, 021021023E, 021721023D, 022221023A, 030121023A, 030221023D, 030221023E, 030221023F, 030821023A, 030921023D, 031021023E, 031621023D, 031721023D, 032221023A, 032421023E, 032521023E, 033021023E, 040521023A, 041421023F, 041521023E, 042121023D, 042621023A, 050521023H, 050621023C, 051221023E, 051221023F, 111620023A, 111620023B, 111820023D, 111820023E, 112320023A and 27 more |
| Model numbers | 30-002-023 |
Product
Verigene EP Amplification Reagent Kit Test
Reason for recall
There is potential for false positive results.
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-2451-2021. 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.