NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
Reported: July 7, 2021 Initiated: May 4, 2021 #Z-1978-2021
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.
Details
- Recalling Firm
- NeuMoDx Molecular Inc
- Units Affected
- 620 cases (29,760 cartridges total)
- Distribution
- Worldwide distribution.
- Location
- Ann Arbor, MI
Frequently Asked Questions
What product was recalled? ▼
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100. Recalled by NeuMoDx Molecular Inc. Units affected: 620 cases (29,760 cartridges total).
Why was this product recalled? ▼
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 7, 2021. Severity: Moderate. Recall number: Z-1978-2021.
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