Device product
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Z-1978-2021
Product summary
- Event
- Event 88099
- Status
- Terminated
- Classification
- Class II
- Quantity
- 620 cases (29,760 cartridges total)
- Official record key
device-enforcement:Z-1978-2021
Official wording
Reason: There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Code information: GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632
Distribution pattern: Worldwide distribution.
Derived failure modes
-
Unknown
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.