Luminex VERIGENE Gram Negative Blood Culture Test Recalled
Luminex is recalling VERIGENE Gram Negative Blood Culture test cartridges due to a consumable issue that may produce incorrect results on a small portion of one lot.
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 of a diagnostic test that may produce false negative results, which is a high-risk scenario where patients could be harmed by undetected bacterial infections even though no illnesses have been reported to date.
Plain-English summary
Luminex Corporation is recalling VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test cartridges (REF 20-006-021) for use with the VERIGENE System. The test is an in vitro diagnostic device used to identify gram-negative bacteria in blood cultures.
A consumable issue in the affected lot may result in "No Call - INT CTL 1" errors and/or false negative results on a small portion of test cartridges. False negative results could lead to delayed or missed bacterial identification.
The recall affects 89 units distributed nationwide to clinical laboratories in Alabama, California, Minnesota, Texas, Arizona, New Jersey, Washington, South Carolina, Virginia, Georgia, Vermont, Connecticut, and Maryland. The affected lot is Lot Number 022525021A (UDI/DI 00840487101599, expiration date 08/26/2025).
Facilities using cartridges from this lot should discontinue use and contact Luminex Corporation for guidance on replacement or disposition of the affected test cartridges.
The recalled product
- Product
- VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
- Manufacturer
- Luminex Corporation
- Affected units
- 89
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/DI 00840487101599
- Lot Number 022525021A
- exp. 08/26/2025
Distribution
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