FDA Device recall Z-1978-2021
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
- FDA Device
- Class II
- terminated
- Published 2021-07-07
On 2021-07-07 the FDA classified a Class II recall of NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 by Neumodx Molecular, citing there is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1978-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-04 |
| Published | 2021-07-07 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Neumodx Molecular |
| Distribution | n/a |
Product
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Reason
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Identifiers
| code_info | GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1978-2021%22
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