Z-1978-2021 Class II Terminated
FDA device recall Z-1978-2021 was initiated by NeuMoDx Molecular Inc on May 4, 2021 and is designated Class II. Reason for recall: There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays. The recall status is terminated (terminated June 21, 2022). Affected quantity: 620 cases (29,760 cartridges total).
Recall Details
- Product Type
- Devices
- Report Date
- July 7, 2021
- Initiation Date
- May 4, 2021
- Termination Date
- June 21, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 620 cases (29,760 cartridges total)
Product Description
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Reason for Recall
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Distribution Pattern
Worldwide distribution.
Code Information
GTIN: 10814278020274; Lot Numbers: 106629 106630 106631 106632