Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Analyzing system consists of a small and portable analyzer and Recalled by HemoCue AB Due to Incorrect version of Quick Reference Guide (QRG) was...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact HemoCue AB directly.
Affected Products
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.
Quantity: 48 affected analyzers
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 17 states: CA, FL, GA, ID, IL, IN, KS, KY, MA, MO, NY, NC, OK, OR, PA, TX, UT
About HemoCue AB
HemoCue AB has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report