Luminex Recalls Verigene Blood Culture Gram-Positive Nucleic Acid Kits
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk diagnostic product where a defect (false negatives) poses a risk of harm to patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits. These in vitro diagnostic tests are used for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria. The recall is being conducted because the product has the potential to lead to false negative results.
The affected product is packaged as five-pack carriers. The specific supplier raw tray lots involved are 195916-070518 and 190943-073118. The associated utility tray lots are 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.
The product was distributed worldwide, including nationwide in the United States and in France. Users of these diagnostic kits should check their inventory for the specific lot numbers listed above and discontinue use of the affected trays.
The recalled product
- 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.
- Manufacturer
- Luminex Corporation
- Hazard
- Affected units
- 12,700
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 081618018C
- 082918018C
- 090418018B
- 081118018C and 082718018B
Distribution
Related recalls
Same manufacturer · Luminex Corporation
See all →- HighLuminex VERIGENE Gram Negative Blood Culture Test Recalled
FDA (Devices) · 2025-06-11
- HighVerigene Gram Positive Blood Culture Test Recalled for Defective Cartridges
FDA (Devices) · 2024-08-14
- ModerateLuminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects
FDA (Devices) · 2023-12-13
- HighVerigene nucleic acid test kits recalled for rare false-negative results
FDA (Devices) · 2023-07-05
- HighVERIGENE Clostridium difficile Nucleic Acid Test May Give False-Negative Results
FDA (Devices) · 2023-07-05
Same hazard · false negative
See all →- HighHealthmark ProChek-II Medical Tests Recalled for Expired Ingredient
FDA (Devices) · 2026-09-02
- HighSiemens Immulite 2000 Syphilis Screen Recall for Negative Bias
FDA (Devices) · 2026-08-26
- HighSiemens Immulite 2000 Syphilis Screen Recalled for Negative Bias
FDA (Devices) · 2026-08-26
- HighHologic Aptima HPV assay may produce invalid or false negative results
FDA (Devices) · 2026-03-25
- HighHeparin antibody test kits recalled over a defect producing negative results
FDA (Drugs) · 2026-01-21