Summary
The FDA issued a Class II for RANDOX Total Bilirubin. by Randox Laboratories Ltd.. Reason: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Metho.
Details
Source
Device Recall
External ID
Z-0501-2024
Action Date
2023-12-13
Status
Ongoing
Category
device
Product Description
RANDOX Total Bilirubin.
Lot/Code Info: Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
Quantity Affected: 1644 units
Reason for Recall
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Distribution
US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-11
Company
Crumlin (North)
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 197 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Randox Laboratories Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Randox Laboratories Ltd. have FDA actions?
Randox Laboratories Ltd. has 39 FDA actions in our database, including 37 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0501-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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