Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Randox NonEsterified Fatty Acids (NEFA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Randox NonEsterified Fatty Acids (NEFA)see related information
Date Initiated by FirmMay 10, 2021
Create DateJuly 20, 2021
Recall Status1 Terminated 3 on November 10, 2021
Recall NumberZ-2099-2021
Recall Event ID 88130
Product Classification Titrimetric, fatty acids - Product Code JLH
ProductNEFA CAL (Non-Esterified Fatty Acids)- IVD Standard for measurement of NEFA Catalog Number: FA115
Code Information Batch Number: 544642 Exp. Date: 28th Nov 2022 GTIN: 05055273203066
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
FDA Determined
Cause 2		Under Investigation by firm
ActionRandox notified the distribution center within the USA via email on 5/10/21.The distributor will then contact the customer directly. Letter states reason for recall, health risk, and action to take: Action to be taken: " Please discard previous value sheets and ensure standard value is updated. " Review results generated with the affected batches in line with the clinical profile of the patient. " Discuss the contents of this notice with your Medical Director
Quantity in Commerce71 kits US
DistributionUS Nationwide Distribution in the states of AR, CA, CT, NY, OH, PA, TN, and TX
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.
-
-