Luminex VERIGENE BC-GP Utility Trays Recalled Due to Potential Defects
Luminex Corporation is recalling 222 kits (4,440 VERIGENE BC-GP Utility Trays) used in blood culture testing due to potentially defective utility trays. The affected lot (062123018C) expires December 20, 2023.
What this means for you
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 recall with no reported illnesses, injuries, hospitalizations, or confirmed harm. The hazard is described as 'potentially defective' without specified mechanism or documented adverse events, fitting criteria for a voluntary precautionary recall.
Plain-English summary
Luminex Corporation is recalling the VERIGENE BC-GP Utility Tray (5-Pack Carrier), REF 20-011-018, a component of the VERIGENE BC-GP Utility Kit (REF 20-012-018) used for gram-positive blood culture nucleic acid testing. The recall affects 222 kits (4,440 utility trays) with lot number 062123018C, expiring December 20, 2023.
The utility trays were distributed nationwide across multiple U.S. states and internationally in Italy.
The product is being recalled due to potentially defective utility trays in the reagent kits.
The recalled product
- Product
- Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
- Manufacturer
- Luminex Corporation
- Hazard
- device-defect
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 (3)
- Lot number 062123018C
- Exp. 12/20/2023
- UDI (01)00840487101674(17)231220(10)062123018C.
Distribution
Distributed nationwide across the United States.
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