medical Class III Updated 2019-04-10

Cypress Medical Products LLC recalls McKesson Consult Diagnostic Immunochemical Fecal Occult Bloo

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, AR, AZ, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MO, MS, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI
Lot/Code Info: All lots
View official government recall

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