Randox Laboratories: Medical Device Recall in 2017 - (Recall #: Z-2167-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class III

Date Initiated: April 27, 2017

Date Posted: June 7, 2017

Recall Number: Z-2167-2017

Event ID: 77152

Reason for Recall:

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

Status: Terminated

Product Quantity: 198 kits

Code Information:

Catalogue number UC5075 Batch number 907UC

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated