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Recall Observatory FDA recall evidence

Device 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

Z-1080-2019

February 27, 2019

Class III

Product summary

Firm
Cypress Medical Products LLC
Event
Event 82312
Status
Terminated
Classification
Class III
Quantity
1165 cases
Official record key
device-enforcement:Z-1080-2019

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.