Z-1080-2019Class III

McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30...

Name: Z-1080-2019 McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30...
Creator: Cypress Medical Products LLC
Published: 2019-02-27
License: https://open.fda.gov/license/

Cypress Medical Products LLC / initiated 2019-02-27 / Terminated / root cause: labeling and UDI

FDA source

Cypress Medical Products LLC began a recall of McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30 on 2019-02-27. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1080-2019
Classification: Class III
Status: Terminated
Initiated: 2019-02-27
Posted: 2019-03-30
Terminated: 2021-05-21
Recalling firm: Cypress Medical Products LLC
Product: McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30
Product code: KHE Reagent, Occult Blood
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.
Root cause tag: labeling and UDI
FDA root cause: No Marketing Application
Action: On February 27, 2019, Cypress Medical Products, LLC, notified their single customer and distributor, McKesson Medical Surgical via Urgent Voluntary Medical Device Recall letter. McKesson then notified their affected distribution centers. The letter instructed the customer to check the stock for affected product. If the customer has affected product, the customer is to cease distribution and quarantine immediately. Recipients were also asked to complete the reply form that was included with the letter, even if you do not have any affected product in your possession at the distribution centers.
Quantity in commerce: 1165 cases
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.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1080-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1080-2019	Class III	Terminated	Voluntary: Firm initiated	2019-04-10	2019-03-30

Product code KHE

K041202Class IIHemosure One-Step Fecal Occult Blood TestW.H.P.M., Inc. / cleared 2004-08-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)