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U.S. Department of Health and Human Services

Enforcement Report - Week of January 9, 2013

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Product Detail

Product Description 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.
Recall Number Z-0619-2013
Classification Class III
Code Info See serial numbers of affected devices in attachment profided by firm.
Product Distributed Qty 48 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.

Event Detail

Event Id 63825
Product Type Devices
Status Ongoing
Recalling Firm HemoCue AB
City Angelholm
Country SE
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-07
Initial Firm Notification of Consignee or Public E-Mail
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.