Verigene Processor heating system may produce false negative results
Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic 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: This is a Class II medical device recall with no reported hospitalizations or injuries. The potential for false negative diagnostic results represents a risk of harm without yet causing reported patient harm, meeting the rubric criterion for High severity.
Plain-English summary
Luminex Corporation is recalling 24 units of the Verigene Processor SP (Models 10-0000-07 and 10-0000-07R), which are components of the Verigene diagnostic system used in clinical laboratories to process patient samples and generate test results.
The heater within the affected processor units may operate outside the established temperature limits required for accurate assays. When temperatures are outside the specified range, test results may be false negatives—meaning a patient with a condition could receive an incorrect negative result, delaying proper diagnosis.
These units were distributed across multiple U.S. states. The FDA and Luminex Corporation have identified specific affected serial numbers for each model variant.
Laboratories and healthcare facilities with these devices should contact Luminex Corporation immediately for verification and repair or replacement instructions. Further information about this Class II recall is available from the FDA.
The recalled product
- Product
- Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
- Manufacturer
- Luminex Corporation
- Affected units
- 24
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 (1)
- 18235008 and 19192006
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 results
See all →- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighBD COR system software issue could produce possible false negative results
FDA (Devices) · 2025-07-30
- HighBioFire Respiratory Panel 2.1 plus Kit recalled for manufacturing defect
FDA (Devices) · 2025-06-04
- HighFilmArra Pneumonia Panel Plus Diagnostic Kit Recalled for Control and Test Failures
FDA (Devices) · 2025-04-16
- HighCandida ID Antigen recalled for reduced sensitivity, potential false negatives
FDA (Devices) · 2025-03-26