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.
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.
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.
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.
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.
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.
Look for the lot number 022525021A and expiration date 08/26/2025 on the test cartridges.
The recalled lot number is 022525021A.
The expiration date is 08/26/2025.
The recall states the cartridges may cause false negative results, but no serious injury is mentioned in the hazard description.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1903-2025 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1903-2025 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.
