Luminex VERIGENE Gram Negative Blood Culture Test Recall: False Negative Risk
Luminex recalls VERIGENE Gram Negative Blood Culture test cartridges due to potential false negatives in small portions of the lot. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
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What happened, in plain English
Luminex is recalling certain VERIGENE Gram Negative Blood Culture test cartridges because they may cause false negative results on a small portion of the lot. This could lead to incorrect blood culture test outcomes, which might affect diagnosis and treatment decisions. Read more at govinfonow.com/recall/52449-luminex-verigene-gram-negative-blood-culture-test-recall-false-negative.
Source Summary by GovInfoNow · govinfonow.com/recall/52449-luminex-verigene-gram-negative-blood-culture-test-recall-false-negative · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1903-2025
Cite this page
“Luminex VERIGENE Gram Negative Blood Culture Test Recall: False Negative Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52449-luminex-verigene-gram-negative-blood-culture-test-recall-false-negative. Based on FDA recall #Z-1903-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2025%22&limit=1).
Why it’s dangerous
The test cartridges may produce false negative results on a small portion of the lot, meaning some tests could incorrectly show no bacteria when bacteria are present. This could lead to missed diagnoses and inappropriate treatment decisions for infections.
Who’s affected
Healthcare facilities using the VERIGENE Gram Negative Blood Culture test cartridges with lot number 022525021A and expiration date 08/26/2025 are affected. Patients receiving blood culture tests using these cartridges may be at risk of incorrect results.
How to tell if you have this one
Check for the lot number 022525021A and expiration date 08/26/2025 on the test cartridges. The product is labeled as VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021 for use with the sample-to-results system.
- Brand
Luminex- Category
Medical device
What to do — step by step
Check Cartridge Lot Number
Look for the lot number 022525021A and expiration date 08/26/2025 on the test cartridges.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
FDA distribution: “US Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC, VA, GA, VT, CT, MD.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Connecticut, Georgia, Maryland, Minnesota, New Jersey, South Carolina, Texas, Vermont, Virginia, Washington.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
Can using the recalled test cartridges cause serious injury?
The recall states the cartridges may cause false negative results, but no serious injury is mentioned in the hazard description.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1903-2025 (April 16, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1903-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.