The Medicines and Healthcare products Regulatory Agency (MHRA) has released a medical device alert for all batches of Uritest 13G urine test strips, manufactured by URIT Medical Electronic and distributed in the UK by Econo-Med Ltd.
The MHRA as found that there is potential for misdiagnosis due to poor analytical precision and sensitivity when testing for low levels of microalbumin and creatinine in urine.
In addition, there is a risk of poor impregnation of the microalbumin and creatinine test pads by the sample, due to their position at the top on the strip, and no instructions for use are provided by the company to aid visual interpretation of the test.
Additional information for patients
As such, the MHRA has advised that the test strips should not be used for the determination of microalbumin or creatinine. For other parameters make sure all test pads are fully immersed into the sample, because the length of the strip can exceed that of the urine sample pots commonly used in the UK. Only use strips with the appropriate analyser, Uritest-500C or Uritest-50, as per instructions.
For more information contact URIT Medical Electronic Co. Ltd by firstname.lastname@example.org faxing +86 773 2883225.