NeuMoDx Molecular Inc recalls specific cartridges for PCR tests due to incorrect labeling that may cause false positive results. Affected lots include 117514, 117524, and 117528.
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
NeuMoDx Molecular Inc is recalling certain PCR cartridges that may have incorrect labels. This could lead to false positive results in nucleic acid tests, which might cause unnecessary concerns or incorrect conclusions.
The label on some cartridges may be misplaced during manufacturing, causing it to interfere with the optical system. This can lead to false positive results in nucleic acid tests, potentially causing incorrect conclusions.
Users of NeuMoDx 288 and 96 Molecular Systems who purchased cartridges with lot numbers 117514, 117524, or 117528 are affected. Laboratory technicians and researchers using these cartridges are most at risk.
Check the lot number on the cartridge packaging. Affected lots are 117514, 117524, and 117528. These cartridges are used with NeuMoDx 288 and 96 Molecular Systems.
Look for lot numbers 117514, 117524, or 117528 on the cartridge packaging.
The label on some cartridges may be misplaced during manufacturing, which can interfere with the optical system and cause false positive results in nucleic acid tests.
Check the lot number on the cartridge packaging. If it matches 117514, 117524, or 117528, contact NeuMoDx Molecular Inc for further instructions.
The hazard is low risk as it only affects test results, not physical safety. False positives may cause unnecessary concerns but do not pose a direct health risk.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-2255-2023 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-2255-2023 from NeuMoDx. 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.
