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
- Hazard
- false-negative-results
- temperature-out-of-range
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
Distributed in 16 states:
- AZ
- CA
- CO
- FL
- GA
- IL
- IN
- KY
- ME
- MI
- NE
- OH
- PA
- TX
- VT
- WA
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01