Recall Z-1786-2024— Randox Laboratories Ltd.

Name: FDA recall Z-1786-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-05

Class III · Ongoing

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2024-04-05. It names one FDA 510(k) clearance: K220451. Product: Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115. Reason: Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Ongoing
Initiated: 2024-04-05
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTATRandox Laboratories Limited·cleared 2023-10-05

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

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine Catalog Number: EV4115

Reason for recall

Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.

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