FDAOctober 12, 2016device

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are quality control materials that are used to assist the laboratory in monitoring test performance throughout the measurable range. They are not calibrators and are not used to calibrate...

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

The hazard

Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

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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