Luminex Recalls Verigene Blood Culture Gram-Positive Nucleic Acid Kits
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits due to a potential for false negative results.
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: The recall involves a high-risk diagnostic product where a defect (false negatives) poses a risk of harm to patient care, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Luminex Corporation is recalling 12,700 trays of Verigene Blood Culture Gram-Positive Nucleic Acid Kits. These in vitro diagnostic tests are used for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria. The recall is being conducted because the product has the potential to lead to false negative results.
The affected product is packaged as five-pack carriers. The specific supplier raw tray lots involved are 195916-070518 and 190943-073118. The associated utility tray lots are 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.
The product was distributed worldwide, including nationwide in the United States and in France. Users of these diagnostic kits should check their inventory for the specific lot numbers listed above and discontinue use of the affected trays.
The recalled product
- Product
- VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (packaged as five-pack carriers) Product Usage: In vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria.
- Manufacturer
- Luminex Corporation
- Hazard
- Affected units
- 12,700
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)
- 081618018C
- 082918018C
- 090418018B
- 081118018C and 082718018B
Distribution
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