Randox Laboratories recalls Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clin…

Recall date

April 27, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2167-2017

FDA classification

Class III

Brand / firm

Randox Laboratories

Sold / distributed

Worldwide Distribution - US Distribution to Puerto Rico and to the countries of : Canada Kuwait Chile Poland China Romania France Saudi Arabia Guatemala Slovenia Iran UAE India UK Italy Uruguay Iraq

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of clinical chemistry systems.