FDAFebruary 15, 2019device

Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The Lipid Profile GLU Cass...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

The polarity of the output of power supply was reversed. Due to polarity of the output of power supplies being reversed, it renders the power supplies nonfunctional and the analyzer inoperable.

What to do

FDA enforcement status: Terminated

Brands named

alere san diegoalerealere san

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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