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.
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
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.
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.
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.
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.
Look for the lot number 031824018A on the test cartridge.
The test cartridges could produce false positive results for Staphylococcus lugdunensis and Enterococcus faecium, which might lead to unnecessary treatments or incorrect diagnoses.
Check the lot number on the cartridge, which should be 031824018A. The expiration date is 09/16/2024, and the product has a GTIN number 00840487101575.
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.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-2533-2024 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-2533-2024 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.