Unrated Medical device recall · FDA · Published February 27, 2019

Cypress Medical Products: McKesson Consult Fecal Blood Test Recall Due to FDA CLIA Waiver

Cypress Medical Products recalls McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Tests (part numbers 178-CK30T, 178-CT30, etc.) due to FDA CLIA waiver denial from packaging similarities to domestic products.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1080-2019Medical device Cypress Medical Products ›

Recall notice

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.

Take action

Contact the company

Recalling firmCypress Medical Products LLC9954 Mayland Dr · Richmond, VA 23233-1464

✎ GovInfoNow plain-language explainer

Cypress Medical Products is recalling certain McKesson Consult fecal occult blood tests because their packaging is too similar to domestically sourced products, which led to the FDA denying CLIA waiver approval. This means the tests may not be legally used in clinical labs without proper regulatory clearance. Read more at govinfonow.com/recall/68936-cypress-medical-products-mckesson-consult-fecal-blood-test-recall-due.

Source Summary by GovInfoNow · govinfonow.com/recall/68936-cypress-medical-products-mckesson-consult-fecal-blood-test-recall-due · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1080-2019

Cite this page

“Cypress Medical Products: McKesson Consult Fecal Blood Test Recall Due to FDA CLIA Waiver.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68936-cypress-medical-products-mckesson-consult-fecal-blood-test-recall-due. Based on FDA recall #Z-1080-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1080-2019%22&limit=1).

Cypress Medical Products LLC voluntarily recalled McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test kits on Feb. 27, 2019, according to the FDA. The agency denied CLIA waiver approval because packaging resembled domestically sourced products under the same label.

How to tell if you have it

Brand: Cypress Medical Products
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
Lots: All lots
Quantity: 1165 cases

The hazard

The products were denied Clinical Laboratory Improvement Amendments (CLIA) waiver approval by the FDA due to packaging being too similar to domestically sourced products under the same branded label.

Context

GovInfoNow's records show Cypress Medical Products LLC has seven other recalls on record since Nov. 17, 2017. Other recent recalls of similar products include GET TESTED Fecal Occult Blood Test Recall (Nov. 3, 2025), DFI One Step K In Vitro Diagnostic Test Recall (April 2, 2026), and Leaky Gut Test Product Recall (Nov. 3, 2025).

How to tell if you have this one

Check for part numbers 178-CK30T, 178-CT30, 178¿TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, or 178¿CK30 on the packaging. All lots are included in this recall.

Brand
Cypress Medical Products
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the part number on the packaging to confirm if it matches the recalled items.

Where it went and when

Where it was distributed

Distributed in 27 states.

FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.2 years after the firm started it.

Feb 27, 2019Firm started the recall
Mar 30, 2019FDA classified it Class III
Apr 10, 2019Published in FDA’s Enforcement Report
May 21, 2021FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

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Keep exploring

More Cypress Medical Products recalls

Link to this recall

<a href="https://govinfonow.com/recall/68936-cypress-medical-products-mckesson-consult-fecal-blood-test-recall-due">Cypress Medical Products: McKesson Consult Fecal Blood Test Recall Due to FDA CLIA Waiver (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1080-2019 (February 27, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1080-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.