Reported Jul 12, 2023 · Ongoing
NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and…
NeuMoDx Molecular Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: NeuMoDx Molecular Inc · 1250 Eisenhower Pl · Ann Arbor, MI · 48108-3281
Is this the product you have?
- NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP)
- REF Number300800
- Lot codes and dates
- GTIN10814278021264
- Lot Number123909 Exp
- Date08-Dec-2023
- Amount recalled
- 1,086 test strips
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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