Recall Z-2557-2019 ยท JJW Urinalysis Controls (Assayed And Unassayed)
Randox Laboratories Ltd.
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.
| Date | Jul 25, 2019 |
| Status | Terminated |
| Reason | Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+. |
| Root cause | Under Investigation by 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 thos |
| Quantity | 1 kit |
| Distribution | US Nationwide distribution including the states of IN, WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110846 | RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2 Randox Laboratories Limited, Sep 30, 2011 |