Recall Z-1978-2021— NeuMoDx Molecular Inc
Class II · Terminated
Class II FDA medical device recall by NeuMoDx Molecular Inc, initiated 2021-05-04, terminated 2022-06-21. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- NeuMoDx Molecular Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-05-04
- Terminated
- 2022-06-21
- Firm location
- Ann Arbor, MI, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.