Date Initiated by Firm |
July 25, 2019 |
Create Date |
September 23, 2019 |
Recall Status1 |
Terminated 3 on December 03, 2020 |
Recall Number |
Z-2557-2019 |
Recall Event ID |
83592 |
510(K)Number |
K110846
|
Product Classification |
Urinalysis controls (assayed and unassayed) - Product Code JJW
|
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. |
Code Information |
Lot: 1020UC Exp. Date: 28 May 2020 |
Recalling Firm/ Manufacturer |
Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
|
Manufacturer Reason for Recall |
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
|
FDA Determined Cause 2 |
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 those who may have received this product. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. |
Quantity in Commerce |
1 kit |
Distribution |
US Nationwide distribution including the states of IN, WV. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = JJW and Original Applicant = RANDOX LABORATORIES LIMITED
|