McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30
FDA Recall Z-1080-2019 · Posted None
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Recalling FirmCypress Medical Products LLC
Recall StatusTerminated
Product CodeKHE
Date Initiated2019-02-27
Date Terminated2021-05-21
Product Quantity1165 cases
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.
Firm 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.
Root Cause
No Marketing Application
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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