Device product
RANDOX Total Bilirubin.
Z-0501-2024
Product summary
- Event
- Event 93387
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1644 units
- Official record key
device-enforcement:Z-0501-2024
Official wording
Reason: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.
Code information: Catalog No. BR8377, BR9766, & BR4061; GTIN: 05055273214772, 05055273208337, & 05055273214765; All Batches.
Distribution pattern: US Nationwide distribution in the states of AR, GA, NC, TN, & PR.
Derived failure modes
-
Unknown
Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method.