Recall Z-0501-2024 ยท JFM Enzymatic Method, Bilirubin
Randox Laboratories Ltd.
RANDOX Total Bilirubin.
| Date | Dec 6, 2023 (initiated Oct 11, 2023) |
| Status | Open, Classified |
| Reason | Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method. |
| Root cause | Device Design |
| Action | Consignees 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 distribu |
| Quantity | 1644 units |
| Distribution | US Nationwide distribution in the states of AR, GA, NC, TN, & PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152344 | Total Bilirubin Randox Laboratories Limited, Jan 28, 2016 |