Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test Recalled by Cypress Medical Products LLC Due to Products were denied Clinical Laboratory Improvement Amendments (CLIA)...

Date: February 27, 2019
Company: Cypress Medical Products LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Cypress Medical Products LLC directly.

Affected Products

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

Quantity: 1165 cases

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 27 states: AL, AZ, AR, CA, CO, FL, GA, HI, IL, KY, LA, MA, MN, MS, MO, NH, NJ, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI

Affected (27 states)Not affected

About Cypress Medical Products LLC

Cypress Medical Products LLC has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report