Luminex recalls Verigene CDF Nucleic Acid Test kits with potential for false negative results due to swab hydrophobicity. Affected kits include specific lot numbers and model parts.
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Luminex is recalling Verigene CDF Nucleic Acid Test kits that may produce false negative results. This could lead to incorrect health diagnoses if used for stool testing.
The swab's hydrophobic characteristics may cause the test to fail to detect certain pathogens, leading to false negative results. This means the test might incorrectly show a negative result when the person actually has an infection.
People who own or use Verigene CDF Nucleic Acid Test kits with the specified lot numbers and part numbers are affected. Those testing for infections using these kits are most at risk.
Check the product label for part number 30-002-22 and lot numbers matching the specific Luminex and FLOQ Swab numbers listed in the recall notice.
Look for part number 30-002-22 and specific lot numbers on the kit.
No, the recall does not require stopping use. The kits may still be used but could produce false negatives.
The recall does not specify a remedy, so no action is required beyond checking the product label.
Check the product label for part number 30-002-22 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1334-2022 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1334-2022 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.
