RANDOX Total Bilirubin recall
RANDOX Total Bilirubin.
Why was RANDOX Total Bilirubin recalled?
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
- Product
- RANDOX Total Bilirubin.
- Recalling firm
- Randox Laboratories Ltd.
- Quantity
- 1644 units
- Distribution
- US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
- Recall date
- December 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)