Reported Jan 9, 2013 · Terminated
Analyzing system consists of a small and portable analyzer and plastic microcuvettes. The microcuvette contains…
HemoCue AB
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: HemoCue AB · Kuvettgaten 1 · Angelholm, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- See serial numbers of affected devices in attachment profided by firm.
- Amount recalled
- 48 affected analyzers
Where it was sold
Why it was 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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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