Class 3 Device Recall DiaScreen Reagent Strips

• Date Initiated by Firm: March 24, 2010
• Date Posted: September 30, 2010
• Recall Status: Terminated on March 08, 2012
• Recall Number: Z-2634-2010
• Recall Event ID: 55680
• 510(K)Number: K981555
• Product Classification: Urine Leukocyte test - Product Code LJX
• Product: Hypoguard, DiaScreen 4pH, Reagent Strips for Urinalysis, 100 strips, Cat. No. D11400.
• Code Information: 03269A, 06089A, 10079A and 11099A
• Recalling Firm/ Manufacturer: ARKRAY USA INC.; 5182 W 76th St; Minneapolis MN 55439-2900
• For Additional Information Contact: 952-646-3168
• Manufacturer Reason for Recall: This recall has been initiated due to a labeling issue with the Hypoguard DiaScreen 4-way pH 100 strips. The front and back panel of the bottle carton lists five reagents when it should only list four reagents. The Ketone reagent should not be included on the label. The test strips contained in the bottle and all other labeling are correct and properly align with 4pH part number D11400 listed on
• FDA Determined Cause: Labeling False and Misleading
• Action: Distributors were sent a Arkray "URGENT: Voluntary Medical Device RECALL " letter dated March 24, 2010. The letter described the problem and the product being recalled. The letter requested the distributors to immediately examine their inventory , quarantine and return the product subject to the recall. If the distributors had further distributed the recalled product, then they were requested to notify the customers of the recall. Arkray enclosed a customer recall letter that the distributors were to use for notifying their customers. Distributors were also contacted by phone on March 24, 2010, and were informed of the recall issue, the product involved, instructed to quarantine the product and to notify their customers.
• Quantity in Commerce: 5504
• Distribution: FL, NJ, MI, NV, FL, OH, GA, WI, NY, KY, LA, CA, CT, TN, IL ISRAEL
• 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 = LJX and Original Applicant = CHRONIMED, INC.