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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 June 22, 2022
Create Date July 20, 2022
Recall Status1 Terminated 3 on May 10, 2024
Recall Number Z-1424-2022
Recall Event ID 90522
510(K)Number K923504  
Product Classification Enzymatic esterase--oxidase, cholesterol - Product Code CHH
Product Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma.
Catalog Number: CH2O0
Code Information GTIN : 05055273201130 Lot Number: 586177  Expiry Date: 28th Jan 2024
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
Manufacturer Reason
for Recall		 Product fails to meet the performance claims quoted on the kit insert: Manual Procedure 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; Cholesterol (CHOL) Instrument Specific Application using the recommended calibration material CAL2351, the product fails to meet its linearity performance claim quoted on the kit inserts. The linearity is reduced by up to -35% however Quality Control results will still fall within assigned ranges. This may lead to delayed results.
FDA Determined
Cause 2		 Process design
Action Randox issued recall notification extended to the distribution center within the USA via email. The distributor will then contact the customer directly. The initial contact and the follow up contact will be via email. If further contacts are required these will be via telephone. It is intended that the initial contact will be conducted week beginning 27 Jun 22. Letter states reason for recall, health risk and action to take: 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.
Quantity in Commerce 15 kits
Distribution Nationwide Distribution - MD, OR, PR, MT, WV
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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