VERIGENE extraction tray reagent defect causes test control failures
Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II medical device with a functional defect affecting a small subset of a single production lot. No reported illnesses, injuries, or hospitalizations. The hazard is limited to test performance failure with no documented patient harm.
Plain-English summary
Luminex Corporation is recalling VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray units (REF 20-009-021, Lot 101321021B) distributed in the United States. A small subset of this extraction tray lot contains a missing reagent, which is essential for proper test operation.
The missing reagent causes higher than normal "No Call Internal Control" failures, meaning the test's quality control check cannot complete properly. This can result in invalid test results or inability to generate a result.
The recall affects 984 units from a single lot. Healthcare facilities and laboratories should discontinue use of affected trays and contact Luminex Corporation for replacements. If affected trays have already been used in testing, laboratories should review the validity of associated test results.
The recalled product
- Product
- VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
- Manufacturer
- Luminex Corporation
- Affected units
- 984
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)
- Lot Number 101321021B
Distribution
Distribution scope not specified by the agency.
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