Recall Z-1057-2019— Randox Laboratories Ltd.

Name: FDA recall Z-1057-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-13

Class II · Terminated

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2019-02-13, terminated 2020-04-14. It names one FDA 510(k) clearance: K093384. Product: Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.. Reason: An error in the assignment of the control range pH in Blood Gas Control.

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Terminated
Initiated: 2019-02-13
Terminated: 2020-04-14
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K093384 — MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3)Diamond Diagnostics, Inc.·cleared 2010-03-10

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 Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

Reason for recall

An error in the assignment of the control range pH in Blood Gas Control

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