Recall Z-0619-2013— HemoCue AB

Name: FDA recall Z-0619-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-07

Class III · Terminated

Class III FDA medical device recall by HemoCue AB, initiated 2012-11-07, terminated 2013-03-14. It names one FDA 510(k) clearance: K053253. 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.. Reason: 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..

Recalling firm: HemoCue AB
Classification: Class III
Status: Terminated
Initiated: 2012-11-07
Terminated: 2013-03-14
Firm location: Angelholm, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K053253 — HEMOCUE ALBUMIN 201 ANALYZING SYSTEMHemocue AB·cleared 2006-02-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.