Recall Z-1107-2019— Randox Laboratories Ltd.

Name: FDA recall Z-1107-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-07

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2019-02-07, terminated 2020-06-08. It names one FDA 510(k) clearance: K112337. Product: Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert. Reason: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Terminated
Initiated: 2019-02-07
Terminated: 2020-06-08
Firm location: Crumlin (North), N/A, Ireland

510(k) clearances named in this recall

1 on FDA's record

K112337 — RANDOX LIQUID IMMUNOASSAY PREMIUM CONTROLS, LEVEL 1, LEVEL2, LEVEL 3 AND TRI LEVELRandox Laboratories, Ltd.·cleared 2011-12-01

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

Liquid Immunoassay Premium Controls, Model Number LIA3105 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert

Reason for recall

The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.

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