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U.S. Department of Health and Human Services

Class 3 Device Recall HemoCue Albumin 201 Analyzer

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  Class 3 Device Recall HemoCue Albumin 201 Analyzer see related information
Date Initiated by Firm November 07, 2012
Date Posting Updated December 28, 2012
Recall Status1 Terminated 3 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 2
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 and Original Applicant = HEMOCUE AB
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