Liquid Urine Control Level 3 For Professional Use in recall: Labeling Error
Liquid Urine Control Level 3 For Professional Use in the quality control monitoring of In-Vitro Diagnostic Urinary Clinical Assays on a range of…
Why was Liquid Urine Control Level 3 For Professional Use in recalled?
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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue number UC5075 Batch number 907UC
- 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…
- Recalling firm
- Randox Laboratories
- 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
- Recall date
- June 7, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)