Z-0501-2024 Class II Ongoing
FDA device recall Z-0501-2024 was initiated by Randox Laboratories Ltd. on October 11, 2023 and is designated Class II. Reason for recall: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. The recall status is ongoing. Affected quantity: 1644 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 13, 2023
- Initiation Date
- October 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1644 units
Product Description
RANDOX Total Bilirubin.
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 Pattern
US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Code Information
Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.