Luminex Verigene Gram Positive Blood Culture Test Recall: False Positive Risk
Luminex recalls Verigene Gram Positive Blood Culture test cartridges that may cause false positives for Staphylococcus lugdunensis and Enterococcus faecium. Affected units have specific lot numbers and expiration dates.
Lower-risk recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Contact the company
What happened, in plain English
Luminex is recalling Verigene Gram Positive Blood Culture test cartridges that could give false positive results for certain bacteria. This might lead to incorrect diagnoses and unnecessary treatments if used without the recall fix. Read more at govinfonow.com/recall/54785-luminex-verigene-gram-positive-blood-culture-test-recall-false-positive.
Source Summary by GovInfoNow · govinfonow.com/recall/54785-luminex-verigene-gram-positive-blood-culture-test-recall-false-positive · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2533-2024
Cite this page
“Luminex Verigene Gram Positive Blood Culture Test Recall: False Positive Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54785-luminex-verigene-gram-positive-blood-culture-test-recall-false-positive. Based on FDA recall #Z-2533-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2024%22&limit=1).
Why it’s dangerous
Defective test cartridges might produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium. This could lead to unnecessary antibiotic treatments or delayed proper care if the test is used without the recall fix.
Who’s affected
Healthcare professionals using the Verigene Gram Positive Blood Culture test cartridges for blood culture analysis. Patients receiving results from these tests may be at risk of incorrect diagnoses.
How to tell if you have this one
Check the lot number on the cartridge, which is listed as 031824018A. The expiration date is 09/16/2024. The product has a GTIN number 00840487101575 and catalog number 20-006-018.
- Brand
Luminex- Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test- Category
Medical device
What to do — step by step
Check Cartridge Lot Number
Look for the lot number 031824018A on the test cartridge.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 25 states.
FDA distribution: “US Nationwide distribution including in the states of AZ, CA, CO, DE, FL, GA, IA, IL, KY, MD, MI, MN, MO, MS, NE, NV, OH, OK, SC, TN, TX, VA, VT, WA, WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Iowa, Kentucky, Maryland, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Vermont, Virginia, Washington, West Virginia.
Recall timeline
FDA published this recall 55 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
Do I need to stop using the test cartridges immediately?
The recall does not require immediate stop use; however, if you have the specific lot number, you should check the cartridges and consider using a different test if needed.
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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-2533-2024 (June 20, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2533-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.