McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test — Class III medical device recall Z-1080-2019
Terminated recall by Cypress Medical Products LLC, reported 2019-04-10, distributed in AL, AR, AZ, CA, CO, FL, GA, HI…. Products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA, due to the
| Recall number | Z-1080-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cypress Medical Products LLC, Richmond, VA, United States |
| Recall initiated | 2019-02-27 |
| Classified | 2019-03-30 |
| Reported by FDA | 2019-04-10 |
| Terminated | 2021-05-21 |
| Distributed | 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 |
| Quantity | 1,165 cases |
| Reason classes | labeling |
| Model numbers | 178-CK30T, 178-CK50, 178-CM25, 178-CM50, 178-CT30, 178-CT50 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1080-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.