NeuMoDx Cartridge recall
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Why was NeuMoDx Cartridge recalled?
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
What should I do if I have this product?
Review the official FDA enforcement record for current 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: 10814278020274; Lot Numbers: 106629 106630 106631 106632
- Product
- NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
- Recalling firm
- NeuMoDx Molecular Inc
- Quantity
- 620 cases (29,760 cartridges total)
- Distribution
- Worldwide distribution.
- Recall date
- July 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)