FDA Medical Device Recalls (openFDA)
Cypress Medical Products LLC: McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30
- Recall number
- Z-1080-2019
- 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
- Status
- Terminated
- Initiated
- 2019-02-27
- Posted
- not on file
- Terminated
- 2021-05-21
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- K041202
- PMA numbers
- not on file
- Product code
- KHE
- Firm FEI
- 1451040
- Firm city
- Richmond
- Firm state
- VA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28