VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits — Class II medical device recall Z-0445-2019
Terminated recall by Luminex Corporation, reported 2018-11-21, distributed nationwide. Potential to lead to a false negative results.
| Recall number | Z-0445-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2018-09-14 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2021-04-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | FR |
| Quantity | 12,700 trays |
| Lot numbers | 081118018C, 081618018C, 082518018C, 082718018B, 082918018C, 090418018B, 190943-073118, 195916-070518 |
Product
VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
Reason for recall
Potential to lead to a false negative 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-0445-2019. 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.