Z-1080-2019 Class III Terminated
FDA device recall Z-1080-2019 was initiated by Cypress Medical Products LLC on February 27, 2019 and is designated Class III. Reason for recall: 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. The recall status is terminated (terminated May 21, 2021). Affected quantity: 1165 cases.
Recall Details
- Product Type
- Devices
- Report Date
- April 10, 2019
- Initiation Date
- February 27, 2019
- Termination Date
- May 21, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1165 cases
Product Description
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
Reason for Recall
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.
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.
Code Information
All lots