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U.S. Department of Health and Human Services

Class 2 Device Recall Randox Cholesterol Kit CH200

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  Class 2 Device Recall Randox Cholesterol Kit CH200 see related information
Date Initiated by Firm November 01, 2021
Create Date December 01, 2021
Recall Status1 Terminated 3 on March 09, 2023
Recall Number Z-0328-2022
Recall Event ID 88999
510(K)Number K923504  
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
Product RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum
REF: CH200
Code Information Lot Numbers/Exp Date: 559344 28th June 2022; 572730 28th July 2023. GTIN: 05055273201130
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
FDA Determined
Cause 2		 Under Investigation by firm
Action Randox USA, Distributor contacted the customer via Urgent Medical Device Correction letter email on 11/1/21. The letter states reason for recall, health risk and action to take: Action to be taken: " Discontinue use of and discard any of the above batches immediately. " Review your reagent inventory of these products and assess your laboratories needs for reimbursement for discarded inventory. " 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. " 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. If you have any questions or concerns please contact Randox Technical Services.
Quantity in Commerce 15 kits
Distribution US Nationwide distribution in the states of GA, OR, PA ,WA, West Virginia.
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.
510(K) Database 510(K)s with Product Code = CHH and Original Applicant = RANDOX LABORATORIES, LTD.
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