Phadia Ab recalls Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including so…

Recall date

July 9, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2397-2019

FDA classification

Class II

Brand / firm

Phadia Ab

Sold / distributed

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

Why it was recalled

code 7-102 Liquid Sensor Error

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.