Z-2167-2017 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- April 27, 2017
- Termination Date
- August 14, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 198 kits
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.
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
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
Code Information
Catalogue number UC5075 Batch number 907UC