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U.S. Department of Health and Human Services

Class 2 Device Recall Total Bilirubin

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 Class 2 Device Recall Total Bilirubinsee related information
Date Initiated by FirmOctober 11, 2023
Date PostedDecember 06, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0501-2024
Recall Event ID 93387
510(K)NumberK152344 
Product Classification Enzymatic method, bilirubin - Product Code JFM
ProductRANDOX Total Bilirubin.
Code Information Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
Recalling Firm/
Manufacturer		 Randox Laboratories Ltd.
55 Diamond Road
Crumlin (North) Ireland
For Additional Information ContactLouise Lynne
44-028-94422413
Manufacturer Reason
for Recall		Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
FDA Determined
Cause 2		Device Design
ActionConsignees were emailed an Urgent Device Correction letter on 10/11/2023. The notice instructed consignees to only use Total Bilirubin Vanadate Oxidation Method on Serum samples, to review results generated with Plasma samples in like with the clinical profiles of the patient, discuss the contents of the recall notice with your facility's Medical Director, and to return the provided response form completed to technical.services@randox.com within 5 working days. The recall notice is to be further distributed to all affected customers and those within consignee organizations, if further distributed. A second recall notification, dated 4/26/24, was sent to consignees identifying the reason for the product issue to be intralipid interference. Reagent IFUs have been updated with sample specific Plasma (lithium heparin) interference claims for intralipids, which can be found on www.randox.com. Consignees are asked to complete and return the provided response form to technical.services@randox.com within five working days.
Quantity in Commerce1644 units
DistributionUS Nationwide distribution in the states of AR, GA, NC, TN, & PR.
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 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) Database510(K)s with Product Code = JFM
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