FDAMay 9, 2016device

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

The hazard

Device was released with default pcal/gain settings for photometers instead of the pcal/gain settings that are required for release. The default settings can potentially lead to the generation of erroneous or invalid results.

What to do

FDA enforcement status: Terminated

Brands named

roche molecular systemsrocheroche molecular

Recall history

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

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