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U.S. Department of Health and Human Services

Class 3 Device Recall Liquid Chemistry Control Premium Plus

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  Class 3 Device Recall Liquid Chemistry Control Premium Plus see related information
Date Initiated by Firm December 13, 2019
Create Date February 06, 2020
Recall Status1 Terminated 3 on October 02, 2020
Recall Number Z-1100-2020
Recall Event ID 84547
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Code Information Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).
FDA Determined
Cause 2		 Error in labeling
Action On December 13, 2019 the firm distributed Urgent Medical Device Recall letters by e-mail stating: Urgent Medical Device Correction Complaint Reference: REC430 Action Type: Device Modification Our records indicate that your facility may have received the following product Detail on Affected Devices: Liquid Clinical Chemistry Control Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE Expiration Date: 30June2020 Manufacturing Date: 21Oct2018 Reason for Recall: A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86). Risk to Health: Control falling out of range could lead to a delay in reporting patient results. See attached HHE. Action to be taken: - Update the affected kits with the correct target values provided. - Discuss the contents of this notice with your Medical Director. - Complete and return the response form 12187-QA to technical.services@randox.com within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concern s, please contact Randox Technical Services.
Quantity in Commerce 2
Distribution US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.
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.
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