Recall Z-1106-2019— Randox Laboratories Ltd.

Name: FDA recall Z-1106-2019
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: K140522. Product: Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 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

K140522 — RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROLRandox Laboratories Limited·cleared 2014-05-22

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

Immunoassay Premium Plus Controls, Model Numbers IA3109 and IA3112 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.