Randox Laboratories Ltd. recalls Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Pr
Recalled 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 test strips.
Hazard / Issue
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Issued by
FDA
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