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FDAApril 25, 2019device

C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

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

The hazard

A reagent in C reactive protein kits is not performing to specification and samples with known concentrations less-than-or-equal to 10 mg/L may be affected

What to do

FDA enforcement status: Terminated

Brands named

binding sitebinding

UPCs

05051700018456

Recall history

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

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