FDA-Device2019-09-04Class II
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
Phadia Ab
Hazard
code 7-102 Liquid Sensor Error
Sold states
US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA
Affected count
387 Instruments
Manufactured in
Rapsgatan Plant, Rapsgatan 7, Uppsala, N/A, Sweden
Products
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2397-2019Don't want to check this manually?
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