Cypress Medical Products LLC recalls McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM2…

Recall date

February 27, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1080-2019

FDA classification

Class III

Brand / firm

Cypress Medical Products LLC

Sold / distributed

Shipped to distribution centers located in 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, and WI.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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