device · product 1 of 1
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
- Initiated
- November 07, 2012
- Classification
- Class III
- Status
- Terminated
- Recalling firm
- HemoCue AB
- Quantity
- 48 affected analyzers
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Sourced
Labeling mix-ups
Inspect official wording and provenance
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.
Code information
See serial numbers of affected devices in attachment profided by firm.
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.