NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and o
Summary
The FDA issued a Class III for NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-Co by NeuMoDx Molecular Inc. Reason: 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.
Details
Source
Device Recall
External ID
Z-2093-2023
Action Date
2023-07-12
Status
Ongoing
Category
device
Product Description
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 Number: 300800
Lot/Code Info: GTIN: 10814278021264 Lot Number: 123909 Exp. Date: 08-Dec-2023
Quantity Affected: 1,086 test strips
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-15
Company
Ann Arbor, MI
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 287 device recalls issued in the same week, part of 403 device-related FDA actions this month.
NeuMoDx Molecular Inc has 7 FDA actions in our database, including 6 recalls and 1 clearance.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (NeuMoDx Molecular Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does NeuMoDx Molecular Inc have FDA actions?
NeuMoDx Molecular Inc has 7 FDA actions in our database, including 6 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2093-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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