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
Product summary
- 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
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.