Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
Lot Codes / Batch Numbers
Lot: 1020UC Exp. Date: 28 May 2020
Products Sold
Lot: 1020UC Exp. Date: 28 May 2020
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland is recalling Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in due to Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Recommended Action
Per FDA guidance
Randox Laboratories notified the distribution center USA by letter dated July 17, 2019 The distributor contacted the customer directly via email on July 25, 2019. The notification states: reason for recall, health risk and action to take: Discard current revision of the Value Sheet and replace with the revised copy available at www.randox.com " Discuss the contents of this notice with your Medical Director. Review results generated with the affected batches in line with the clinical profile of the patient. " Please retain this letter with your laboratory records and forward this letter to those who may have received this product. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026