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.
Enforcement
- Recall Number
- Z-2167-2017
- Event ID
- 77152
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Randox Laboratories
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- June 7, 2017
- Initiation Date
- April 27, 2017
- Classification Date
- May 26, 2017
- Termination Date
- August 14, 2017
- Address
- 515 Industrial Blvd, Kearneysville, WV, 25430-2778, United States
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.
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
Catalogue number UC5075 Batch number 907UC
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
198 kits