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U.S. Department of Health and Human Services

Class 3 Device Recall Randox Urinalysis Control Level 2

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 Class 3 Device Recall Randox Urinalysis Control Level 2see related information
Date Initiated by FirmJuly 25, 2019
Create DateSeptember 23, 2019
Recall Status1 Terminated 3 on December 03, 2020
Recall NumberZ-2557-2019
Recall Event ID 83592
510(K)NumberK110846 
Product Classification Urinalysis controls (assayed and unassayed) - Product Code JJW
ProductRandox 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
FEI Number 1000361607
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
ActionRandox 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 Commerce1 kit
DistributionUS Nationwide distribution including the states of IN, WV.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JJW
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