Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on ...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2167-2017.
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
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2167-2017.
Recall terminated by FDA.
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- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-2167-2017.
Randox Laboratories
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Randox Laboratories Recall FAQ
Randox Laboratories is the subject of a diagnostic devices safety report: Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on .... The notice was published on April 27, 2017 by the U.S. Food and Drug Administration (FDA). Approximately 198 units are potentially affected.