Recall Z-1547-2020— Randox Laboratories Ltd.

Name: FDA recall Z-1547-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-18

Class II · Ongoing

Class II FDA medical device recall by Randox Laboratories Ltd., initiated 2020-02-18. It names one FDA 510(k) clearance: K140971. Product: Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.. Reason: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly..

Recalling firm: Randox Laboratories Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2020-02-18
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K140971 — LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3.Randox Laboratories Limited·cleared 2014-12-08

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

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

Reason for recall

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

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