FDAFebruary 27, 2019device

McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178¿CK30

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

The hazard

Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the packaging being too similar to domestically sourced products under the same branded label.

What to do

FDA enforcement status: Terminated

Brands named

cypress medical productscypresscypress medical

Recall history

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

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