Class 3 Device Recall HemoCue Glucose 201 Microcuvettes,

• Date Initiated by Firm: May 30, 2011
• Date Posted: January 20, 2012
• Recall Status: Terminated on March 02, 2012
• Recall Number: Z-0824-2012
• Recall Event ID: 60539
• 510(K)Number: K020935
• Product Classification: Glucose oxidase, glucose - Product Code CGA
• Product: HemoCue Glucose 201 Microcuvettes, ; ; Article Number:110705*,110706,110715**,110716**,110717**,110718**,; 110719**; ; ; " No affected lots of this article have been delivered to customers. Still; in stock at distributor HemoCue Inc.; "" Article not available in US; ; ; Quantitative determination of glucose in whole blood, using a specially designed analyzer, the HemoCue Glucose 201 Analyzer. The quantitative determination of the instant blood glucose concentration in circulation supplements the clinical evidence in the diagnosis and treatment of patients with diabetes as well as monitoring of neonatal blood glucose levels. HemoCue Glucose 201 Microcuvettes are for In Vitro Diagnostic use only and are only to be used with the HemoCue Glucose 201 Analyzer. For professional use only.
• Code Information: Lot/batch Number: US: 1011383*, 1102471 *,1102474*,1102487*,1103200*, 1103201**,1103236*,1103213*,1103216*,1103224*, 1103225*,1103226*,1103238*,1103243**,1103246*, 1103250*,1103496*,1103498*,1104272**,1104273**, 1104288**,1104289**,1104548**,1104549**,1104550**, 1104555**,1104556**,1104558**,1104559**,1103212*, 1103240*,1104557** * lots have been shipped to customers ** lots are in stock at distributor HemoCue Inc. Not in US: 1104282, 1105306, 1104530, 1103242, 1103241, 1103244,1103247,1104255,1104258,1103248,1103234, 1104260,1104267,1104274,1104270,1102467,1104277, 1104531,1104532,1104533,1104534,1104535,1103227, 1103228,1103232,1103230,1103233,1104254,1104256, 1103249,1104254,1103245,1104263,1104274,1104286, 1104275,1104283. The lots that are not for the US market are not affected by the labeling infonnation regarding lithium heparin.
• Recalling Firm/ Manufacturer: Hemo Cue, Inc.; 11331 Valley View St; Cypress CA 90630-5366
• Manufacturer Reason for Recall: A recall was initiated because Hemocue confirmed that the package insert for Hemocue Glucose 201 Microcuvettes had errors in two sections.
• FDA Determined Cause: Packaging process control
• Action: HemoCue sent a Medical Device Correction Notification letter dated June 14, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to passed on the notice to all that need to be aware with their organization or to any organization where the affected lot numbers have been distributed. Customers were instructed to sign the Correction Notification Verification form below and return to HemoCue Inc. Customers received the revised package insert with the notification letter. Customers with any questions regarding the Correction Notification could please call (562) 668-5665.
• Quantity in Commerce: 13,620 packages
• Distribution: Worldwide Distribution--USA (nationwide) and the countries of Czech Republic, Denmark, Slovenia, Norway, Sweden, Switzerland, United Kingdom, Finland, Germany, Netherlands, Poland, Romania, and Tanzania.
• 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 = CGA and Original Applicant = HEMOCUE, INC.