Class 2 Device Recall MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for SelfTesting & MultiPa

• Date Initiated by Firm: October 02, 2013
• Date Posted: February 03, 2014
• Recall Status: Terminated on January 28, 2016
• Recall Number: Z-0909-2014
• Recall Event ID: 67152
• 510(K)Number: K090495
• Product Classification: System, test, blood glucose, over the counter - Product Code NBW
• Product: MooreMedical Supporting Health & Care...MooreBrand Blood Glucose Monitor for Self-Testing & Multi-Patient Use TRUEbalance. Manufactured by: NIPRO DIAGNOSTICS, Fort Lauderdale, FL 33309 U.S.A. Is intended for the quantitative determination of glucose in human whole blood taken from finger or forearm.
• Code Information: Finished Good: KK0468; Lot Numbers: KL01079, KM0337TI, KN1834TI, KN1973TI, KN2074TI, KN 2089TI, KN2090TI, KN2102TI, KP0047TI, KP0076TI, KP0128TI, KP0925TI.
• Recalling Firm/ Manufacturer: Nipro Diagnostics, Inc.; 2400 NW 55th Ct; Ft Lauderdale FL 33309-2672
• For Additional Information Contact: Lisa Nardi; 954-677-9201
• Manufacturer Reason for Recall: Manufactured with an incorrect factory set unit of measure.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Nipro Diagnostics sent an Urgent Medical Device Voluntary Recall letter dated December 31, 2013 to all affected customers. The customers were instructed to do the following: 1) Screen their inventory immediately for any of the serial numbers listed on the back of the products. 2) If they have any of the affected products, return the product by contacting Stericycle at 1-866-236-4518. 3) Complete and return the enclosed response form via fax at 1-888-358-7294. Customers with questions were instructed to call Stericycle at 1-866-236-4518. For questions regarding this recall call 954-677-9201.
• Quantity in Commerce: 501
• Distribution: Worldwide Distribution - USA (nationwide, HI and Puerto Rico and Internationally to Canada, European Union, Jamaica, Suriname, Trinidad and Tobago, Kazakhastan, Russian, Turkey, Australia, Bangladesh, Pakistan, Cambodia, Laos, Myanmar, Thailand, Vietnam, and India.
• 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 = NBW