Recall Z-0501-2024— Randox Laboratories Ltd.

Name: FDA recall Z-0501-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-11

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2023-10-11. It names one FDA 510(k) clearance: K152344. Product: RANDOX Total Bilirubin.. Reason: Randox has had reports of elevated patient results using Plasma (lithium heparin) samples with Total Bilirubin reagent (TBil) Vanadate Oxidation Method..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2023-10-11
Firm location: Crumlin (North), Ireland

510(k) clearances named in this recall

1 on FDA's record

K152344 — Total BilirubinRandox Laboratories Limited·cleared 2016-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.