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FDAOctober 26, 2016device

Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the quantification of Intact Parathyroid Hormone (PTH) in serum.

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

The hazard

There may be a loss of separation between Calibrators A and B which may impact the assay calibration at the lower end of the assay.

What to do

FDA enforcement status: Terminated

Brands named

diagnostic hybridsdiagnostic

Recall history

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

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