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 G6PDH CONTROL D

  • 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 G6PDH CONTROL Dsee related information
Date Initiated by FirmApril 03, 2019
Create DateMay 03, 2019
Recall Status1 Terminated 3 on October 09, 2019
Recall NumberZ-1254-2019
Recall Event ID 82550
Product Classification Glucose-6-phosphate dehydrogenase (erythrocytic), quantitative - Product Code JBL
ProductG-6-PDH Deficient Control (G-6-PDH CONTROL D), Catalogue Number PD2617 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes
Code Information Lot Numbers: 687PD 700PD 715PD
FEI Number 1000361607
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		The target values and ranges in these lots are incorrect.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionRandox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " 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. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to technical.services@randox.com within five working days. For questions contact Randox Technical Services.
Quantity in Commerce14 kits
DistributionThe products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.
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.
-
-