Randox Laboratories Recalls
Showing 1-3 of 3 recalls
RX Imola (RX4900) For Professional Use for the quantitative in vitro determination of various clinical chemistry tests.
Abnormal premature termination of the software could affect the use of the analyser when running patient samples. The impact being a delay in reporting test results.
All customers will be contacted directly by email and will be followed up with once every 2 weeks over a period of 6 weeks. Customers are advised to update the software in all analyzers. For further questions, please call 1 (866)472-6369.
Immunoassay Premium Controls (3x4x5mL and 12x5mL packages)
The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
On July 24, 2017 an Urgent notice was issued instructing customers to place a copy a notice in all kits remaining in stock. This notifies customers that they should amend the claims for open stability in the instructions for use, to state use immediately after the 30 minute reconstitution period. Questions or concerns can be emailed to technical.services@randox.com
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
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.