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.
Reported: October 2, 2019 Initiated: July 25, 2019 #Z-2557-2019
Product Description
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.
Reason for Recall
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Details
- Recalling Firm
- Randox Laboratories Ltd.
- Units Affected
- 1 kit
- Distribution
- US Nationwide distribution including the states of IN, WV.
- Location
- Crumlin (North)
Frequently Asked Questions
What product 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.. Recalled by Randox Laboratories Ltd.. Units affected: 1 kit.
Why was this product recalled? ▼
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 2, 2019. Severity: Low. Recall number: Z-2557-2019.
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