Recall Z-2083-2019— Randox Laboratories, Limited

Name: FDA recall Z-2083-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-24

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories, Limited, initiated 2019-06-24, terminated 2020-05-21. It names one FDA 510(k) clearance: K131554. Product: RX Daytona, Model Nos. RX4040 and RX4041. Reason: There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument..

Recalling firm: Randox Laboratories, Limited
Classification: Class II
Status: Terminated
Initiated: 2019-06-24
Terminated: 2020-05-21
Firm location: Crumlin, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENTRandox Laboratories, Ltd.·cleared 2014-01-09

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

RX Daytona, Model Nos. RX4040 and RX4041

Reason for recall

There was a report of a malfunction with the sensor which resulted in an increase of temperature leading to melting of internal wires and scorch damage to the internal structure of the instrument.

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