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U.S. Department of Health and Human Services

Class 2 Device Recall G6PDH CONTROL N

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 Class 2 Device Recall G6PDH CONTROL Nsee related information
Date Initiated by FirmApril 03, 2019
Create DateMay 03, 2019
Recall Status1 Terminated 3 on October 09, 2019
Recall NumberZ-1255-2019
Recall Event ID 82550
Product Classification Glucose-6-phosphate dehydrogenase (erythrocytic), quantitative - Product Code JBL
ProductG-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 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: 676PD 701PD 716PD
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 Commerce10 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.
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