NeuMoDx recalls specific SARS-CoV-2 test cartridges that may cause false positive results, leading to incorrect patient management. Affected lots include 115424-115431.
Potential for false positive results for SARS-CoV-2 in identified lots of cartridges, when used in conjunction with assays containing SARS-CoV-2 targets (NeuMoDx" SARS-CoV-2 Test Strip Cat #300800 and NeuMoDx" Flu A-B/RSV/SARS-CoV-2 Vantage Assay Cat #300900) result incorrect management of patients
NeuMoDx is recalling certain SARS-CoV-2 test cartridges that could give false positive results, which might lead to incorrect patient treatment. This recall affects specific lots of cartridges sold with certain test strips.
These cartridges, when used with certain SARS-CoV-2 tests, may produce false positive results. This could lead to incorrect patient management decisions, such as unnecessary isolation or treatment.
Healthcare professionals using NeuMoDx SARS-CoV-2 test cartridges with specific lot numbers may be affected. Patients receiving incorrect treatment due to false positives could be at risk.
Check the lot numbers on the cartridge: 115424, 115425, 115426, 115427, 115429, or 115431. The cartridges are used with NeuMoDx SARS-CoV-2 Test Strip (REF 300800) or Flu A-B/RSV/SARS-CoV-2 Vantage Assay (REF 300900).
Look for lot numbers 115424-115431 on the cartridge packaging.
The recall is for potential false positive results, which could lead to incorrect patient management, but the risk of serious injury is not described.
Cartridges used with NeuMoDx SARS-CoV-2 Test Strip (REF 300800) or Flu A-B/RSV/SARS-CoV-2 Vantage Assay (REF 300900).
Check the lot numbers on the cartridge: 115424, 115425, 115426, 115427, 115429, or 115431.
We’ve drafted a message you can send NeuMoDx to request your refund or repair — edit it as you like.
Subject: Recall Z-1000-2022 — NeuMoDx NeuMoDx Hello, I own a NeuMoDx that is covered by recall Z-1000-2022 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.
