Reported Oct 2, 2019 · Terminated
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in…
Randox Laboratories Ltd.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Randox Laboratories Ltd. · 55 Diamond Road · Crumlin (North) · N/A
Is this the product you have?
- Randox
- Urinalysis Control Level 2 (IVD) RefUC5034 -
- Product UsageProduct is intended for in vitro diagnostic use in the quality control of urine test strips
- Lot codes and dates
- Lot1020UC Exp
- Date28 May 2020
- Amount recalled
- 1 kit
Where it was sold
Why it was recalled
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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