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U.S. Department of Health and Human Services

Class 3 Device Recall McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test

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  Class 3 Device Recall McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test see related information
Date Initiated by Firm February 27, 2019
Create Date March 30, 2019
Recall Status1 Terminated 3 on May 21, 2021
Recall Number Z-1080-2019
Recall Event ID 82312
510(K)Number K041202  
Product Classification Reagent, occult blood - Product Code KHE
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
Code Information All lots
Recalling Firm/
Manufacturer		 Cypress Medical Products LLC
9954 Mayland Dr
Richmond VA 23233-1464
For Additional Information Contact Jill Early
804-553-2146
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KHE and Original Applicant = W.H.P.M., INC.
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