Liquid Urine Control Level 3 의 리콜

Recall

77152

Class 3

Z-2167-2017

2017-04-27

2017-05-26

Terminated

United States

2017-08-14

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155040

According to randox laboratories an investigation indicates a labelling error for 2 of the test methods listed for quantification of total protein (urine). the values for the mean of all instruments are incorrect by a factor of 10. instrument specific values are correct. this does not affect the performance or stability claims of the product. as control results will be outside of the quoted range this may result in a delay in reporting the sample test results. however as the correct instrument specific means are also included in the value sheet this delay is unlikely. customers have been referred to their medical director for further advice.

Randox Laboratories will contact Customers directly by e-mail and will be followed up with once every 2 weeks over a period of 6 weeks. There are no plans in place to follow up with customers after the 6 week period. For further questions, please call (304) 728-2890.