# FDA recall Z-1080-2019

> **Cypress Medical Products LLC** · Class III · device recall initiated 2019-02-27.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-1080-2019
- **Recalling firm:** Cypress Medical Products LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-27
- **Report date:** 2019-04-10
- **Termination date:** 2021-05-21

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Richmond, VA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1080-2019

## Citation

> AI Analytics. FDA recall Z-1080-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-1080-2019. Source: US FDA. Licensed CC0.

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