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FDAFebruary 1, 2023device

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above

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

The hazard

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

What to do

FDA enforcement status: Ongoing

Brands named

quidel

UPCs

30014613335580

Recall history

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

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