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U.S. Department of Health and Human Services

Class 2 Device Recall Liquid Assayed Chemistry Control Premium Plus Level 3

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  Class 2 Device Recall Liquid Assayed Chemistry Control Premium Plus Level 3 see related information
Date Initiated by Firm August 03, 2023
Date Posted September 19, 2023
Recall Status1 Open3, Classified
Recall Number Z-2609-2023
Recall Event ID 92912
510(K)Number K140971  
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
Product Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Code Information UDI-DI: 05055273208986; Lot Number: 1308UE
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
FDA Determined
Cause 2		 Under Investigation by firm
Action A Medical Device Correction notification letter dated 8/3/23 was sent to customers. Action to be taken: " Review Quality Control data generated using the affected lot. " 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 organisation. Please accept our apologies for any inconvenience caused. Thank you for your patience and understanding. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce 66 kits
Distribution US States: GA, OH, OR, PA, TX, VA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JJY and Original Applicant = RANDOX LABORATORIES LIMITED
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