NeuMoDx SARS-CoV-2 Assay -IVD intended for the recall
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport…
Why was NeuMoDx SARS-CoV-2 Assay -IVD intended for the recalled?
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 instrument registers the non-human readable text as lot number 123910 from the barcode label.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
- Product
- NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport…
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 1,086 test strips
- Distribution
- US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
- Recall date
- July 12, 2023
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (device)