NeuMoDx Molecular Inc Recall 88099
Description: NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
NeuMoDx Molecular Inc Recall 88099 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1978-2021 |
| Event ID | 88099 |
| Event Description | NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100 |
| Product Type | Devices |
| Distribution | Worldwide distribution. |
| Quantity | 620 cases (29,760 cartridges total) |
| Recall Reason | There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. |
| Device Classification | 20210707 |
| Device Code Info | GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632 |
| Center Classification Date | 20210629 |
| Recall Initiation Date | 20210504 |
| Recalling Firm | NeuMoDx Molecular Inc |
| Initial Notification | Letter |
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