Class 3 Device Recall HemoCue Albumin 201 Analyzer

• Date Initiated by Firm: November 07, 2012
• Date Posted: December 28, 2012
• Recall Status: Terminated on March 14, 2013
• Recall Number: Z-0619-2013
• Recall Event ID: 63825
• 510(K)Number: K053253
• Product Classification: Turbidimetric method, protein or albumin (urinary, non-quant.) - Product Code JIQ
• Product: Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains reagents deposited on its inner walls. The urine sample is drawn into the cavity by capillary action. The filled cuvette is inserted into the device where the contents of the cuvette are mixed through vibration. Within 90 seconds, the immunochemical reaction is completed and the turbidity is measured photometrically at 610 nm. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria.
• Code Information: See serial numbers of affected devices in attachment profided by firm.
• Recalling Firm/ Manufacturer: HemoCue AB; Kuvettgaten 1; Angelholm Sweden
• For Additional Information Contact: Shilpi Sinha; 562-668-5692
• Manufacturer Reason for Recall: Incorrect version of Quick Reference Guide (QRG) was delivered with products in shipment made from April1 st 2011 and onwards. In addition, a warranty statement was missing in the analyzer package.
• FDA Determined Cause: Labeling mix-ups
• Action: HemoCue sent an "IMPORTANT MEDICAL DEVICE CORRECTION NOTIFICATION" letter dated November 7, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Correction Notification Verification Form was included for customers to complete and return. Contact the firm at 562-668-5741 for questions regarding this notification.
• Quantity in Commerce: 48 affected analyzers
• Distribution: Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
• 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 = JIQ