NeuMoDx Molecular Inc recalls specific model cartridges for in vitro diagnostics due to potential false positive results with certain assays. Affected lots: 106629-106632.
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
NeuMoDx Molecular Inc is recalling specific cartridges for their 288 and 96 Molecular Systems. These cartridges could give false positive results when used with certain tests, which might lead to incorrect health conclusions.
The cartridges may produce false positive results when used with specific diagnostic assays. This could lead to incorrect health conclusions if the tests are used for medical purposes. The risk is limited to certain lots and specific assay combinations.
Users of NeuMoDx 288 and 96 Molecular Systems with specific cartridge lots (106629-106632) are affected. Laboratory professionals using these cartridges for in vitro diagnostics are most at risk.
Check if your NeuMoDx 288 or 96 Molecular System uses cartridges labeled Model Number 100100 with lot numbers 106629 through 106632.
Look for the lot number on the cartridge packaging; affected lots are 106629 to 106632.
No, the recall does not require immediate stop use. The risk is limited to specific lots and assay combinations.
The recall does not specify a remedy, so no action is required beyond checking the lot number.
The recall is specific to NeuMoDx Cartridge Model Number 100100 with the listed lot numbers.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1978-2021 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-1978-2021 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.
