NeuMoDx Molecular Inc recalls NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test…
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…
Read the official notice →- Date
- 2022-05-04
- Country
- United States
- Brand
- NeuMoDx Molecular
- Product
- NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of OH, MO,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The…
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There is a potential for reduced analytical sensitivity for samples in the 1x - 3x LOD range for Flu A, RSV, and SARS-CoV-2 targets. This may lead to false negative results, allowing ongoing transmission to others and…
FDA · DeviceNeuMoDx Molecular IncDomestic distribution to FL, NY, MD, PA, VA, MI, TN, NM. Foreign distribution…Official notice → - 2022-03-16
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A risk for product contamination was identified for the affected product lot. If used, there is an increased potential for SARS-CoV-2 false positive results when using the product.
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