Verigene Gram Positive Blood Culture Test Recalled for Defective Cartridges
Luminex recalls approximately 1,100 diagnostic kits due to defective test cartridges that may produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium bacteria.
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 3/5 (High).
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: FDA Class II recall affecting diagnostic test accuracy. The hazard is a risk of false positive results that could lead to inappropriate treatment, but no illnesses or injuries have been reported. This fits the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Luminex Corporation is recalling approximately 1,100 kits of the Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test, a diagnostic system used to identify bacteria in blood cultures.
The recall was issued due to potential defects in test cartridges that may result in false positive results. Specifically, the affected cartridges may incorrectly identify the presence of Staphylococcus lugdunensis and Enterococcus faecium bacteria even when these organisms are not actually present in the sample.
The affected kits were distributed nationwide. The recall applies to kit lot number 031824018A with an expiration date of September 16, 2024. Affected healthcare facilities and laboratories should stop using the recalled kits.
Patients or healthcare providers who believe they may have been affected by false test results should consult with a healthcare professional to determine whether retesting or additional evaluation is warranted.
The recalled product
- Product
- Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- Manufacturer
- Luminex Corporation
- Affected units
- 1,100
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 (4)
- GTIN Number: 00840487101575
- Catalog Number: 20-006-018
- Lot Number: 031824018A
- Expiration Date: 09/16/2024
Distribution
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