McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test, Part numbers 178-CK30T, 178-CT30, 178TBSO, 178-CM25, 178-CK50, 178-CM50, 178-CT50, 178CK30
This recall has been terminated (originally issued February 27, 2019).
- Company
- Cypress Medical Products Llc
- Recall Initiated
- February 27, 2019
- Terminated
- May 21, 2021
- Recall Number
- Z-1080-2019
- Quantity
- 1165 cases
- Firm Location
- Richmond, VA
- Official Source
- View on FDA website ↗
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.
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 / Code Info
All lots
Root Cause
No Marketing Application
Action Taken
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.