Luminex recalls xTAG Gastrointestinal Pathogen Panel kits with lower MS2 MFI values. Affected lots expire by 12/31/2018 and 4/30/2019. No remedy specified in recall notice.
Reports have been received of lower MS2 MFI values when using the panel.
Luminex is recalling certain xTAG Gastrointestinal Pathogen Panel kits that may show lower MS2 MFI values. This could affect test accuracy for detecting pathogens in stool samples. The recall is for specific lot numbers with expiration dates up to 4/30/2019.
The recall reports lower MS2 MFI values in certain kits, which may lead to inaccurate test results for detecting gastrointestinal pathogens. This could affect the reliability of test outcomes for viral, bacterial, and parasitic infections in stool samples.
Users of the xTAG Gastrointestinal Pathogen Panel kits with specific lot numbers (IK032C-00061 to IK032C-00071) are affected. Laboratory personnel and healthcare providers using these kits for stool testing are most at risk.
Check the lot number on the kit label, which starts with IK032C. The affected lots expire by 12/31/2018 or 4/30/2019. The product is a laboratory test kit for stool samples.
Look for the lot number on the kit label, which starts with IK032C.
Reports have been received of lower MS2 MFI values when using the panel, which could affect test accuracy.
The xTAG Gastrointestinal Pathogen Panel is a laboratory test kit for detecting viral, bacterial, and parasitic nucleic acids in human stool samples.
The recall notice does not specify a remedy, so no action is required beyond checking the lot number.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-1767-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-1767-2019 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.
