NeuMoDx Molecular Inc recalls NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
- Recall date
- May 4, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1978-2021
- FDA classification
- Class II
- Brand / firm
- NeuMoDx Molecular Inc
- Sold / distributed
- Worldwide distribution.
Why it was recalled
There is a potential for false positive results when certain lots of cartridges are used in conjunction with specific assays.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
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