Cypress Medical Products LLC: Medical Device Recall in 2019 - (Recall #: Z-1080-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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

Product Classification:

Class III

Date Initiated: February 27, 2019

Date Posted: April 10, 2019

Recall Number: Z-1080-2019

Event ID: 82312

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.

Status: Terminated

Product Quantity: 1165 cases

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.

Voluntary or Mandated:

Voluntary: Firm initiated