FDA-Device2018-01-24Class II

Phadia 1000 Instrument, Article Number 12-3800-01.

Phadia US Inc
Hazard

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

Sold states
Nationwide
Affected count
70 units
Manufactured in
4169 Commercial Ave, N/A, Portage, MI, United States
Products
Phadia 1000 Instrument, Article Number 12-3800-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0387-2018

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