NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Summary
The FDA issued a Class II for NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 by NeuMoDx Molecular Inc. Reason: There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays..
Details
Source
Device Recall
External ID
Z-1978-2021
Action Date
2021-07-07
Status
Terminated
Category
device
Product Description
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Lot/Code Info: GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632
Quantity Affected: 620 cases (29,760 cartridges total)
Reason for Recall
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Distribution
Worldwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-04
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 52 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-1978-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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