Randox Laboratories Ltd. recalls Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in…
- Recall date
- July 25, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2557-2019
- FDA classification
- Class III
- Brand / firm
- Randox Laboratories Ltd.
- Sold / distributed
- US Nationwide distribution including the states of IN, WV.
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+.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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.
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