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.
FDA Recall Z-2557-2019 · Posted None
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Recalling FirmRandox Laboratories Ltd.
Recall StatusTerminated
Product CodeJJW
Date Initiated2019-07-25
Date Terminated2020-12-03
Product Quantity1 kit
Reason for Recall
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
Firm Action
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 [email protected] within five working days.
Root Cause
Under Investigation by firm
Distribution Pattern
US Nationwide distribution including the states of IN, WV.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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