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.
FDA Recall Z-0619-2013 · Posted 2012-12-28
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Recalling FirmHemoCue AB
Recall StatusTerminated
Product CodeJIQ
Date Initiated2012-11-07
Date Terminated2013-03-14
Product Quantity48 affected analyzers
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Distributed in the states of FL, MA, CA, OR, NY, NC, MO, ID, IN, KY, PA, TX, OK, IL, GA, KS, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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