Randox Urinalysis Control Level 2 recall
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine…
Why was Randox Urinalysis Control Level 2 recalled?
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
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?
Lot: 1020UC Exp. Date: 28 May 2020
- Product
- Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine…
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1 kit
- Distribution
- US Nationwide distribution including the states of IN, WV.
- Recall date
- October 2, 2019
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)