NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and
Summary
The FDA issued a Class II for NeuMoDx Cartridge-used for extraction, purification, amplification and detection by NeuMoDx Molecular Inc. Reason: Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroac.
Details
Source
Device Recall
External ID
Z-2255-2023
Action Date
2023-08-09
Status
Ongoing
Category
device
Product Description
NeuMoDx Cartridge-used for extraction, purification, amplification and detection of nucleic acids on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems (NeuMoDx System(s) Ref: 100100
Lot/Code Info: GTIN: 10814278020274 Lot Numbers: 117514, 117524, and 117528
Quantity Affected: 20,016 cartridges
Reason for Recall
Top label on some of the NeuMoDx cartridges within these lots may have been incorrectly applied during the manufacturing process, resulting in encroachment into the PCR region. The misplaced label may interfere with the module s optics performance, thereby increasing the risk for false positive results
Distribution
US Nationwide Distribution to states of: Kansas, Florida, Texas, Ohio, New York, Michigan, Pennsylvania; and OUS (Foreign) to countries of: AT, BE, CH, DE, ES, FI, FR, GB, IT, LV, PL, RO, SE
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-24
Company
Ann Arbor, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 202 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-2255-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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