Luminex Recalls Verigene BC-GP Utility Kits Due to Labeling Error
Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a labeling error, which falls under the 'Low' severity criteria for documentation or packaging-only problems.
Plain-English summary
Luminex Corporation is recalling 1,132 carriers of Verigene BC-GP Utility Kits (REF 20-011-018). The recall was initiated because the utility kits were labeled with the Verigene Amplification Tray label instead of the correct utility kit label.
The affected lots are 110318018C and 111018018D. The product is distributed worldwide, including the United States, Austria, and Italy. The Verigene BC-GP test is an in vitro diagnostic used to detect and identify gram-positive bacteria in blood cultures.
Users should stop using the affected kits and contact Luminex Corporation for instructions on how to return or dispose of the product.
The recalled product
- Product
- Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and…
- Manufacturer
- Luminex Corporation
- Hazard
- Affected units
- 1,132
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)
- UDI: 00857573006287
- Lots: 110318018C
- 111018018D
Distribution
Distributed nationwide across the United States.
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