Recall Z-2167-2017
Randox Laboratories · initiated April 27, 2017
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: Catalogue number UC5075 Batch number 907UC
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
FDA-determined cause: Error in labeling
Action taken
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.
Details
- Recall number
- Z-2167-2017
- Initiated
- April 27, 2017
- Posted by FDA
- May 26, 2017
- Terminated
- August 14, 2017
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Quantity
- 198 kits
- Distribution
- 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
- Recalling firm
- Randox Laboratories, Kearneysville, WV