Recall Z-1100-2020— Randox Laboratories Ltd.

Name: FDA recall Z-1100-2020
Creator: U.S. Food and Drug Administration
Published: 2019-12-13

Class III · Terminated

Class III FDA medical device recall by Randox Laboratories Ltd., initiated 2019-12-13, terminated 2020-10-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml. Reason: A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86)..

Recalling firm: Randox Laboratories Ltd.
Classification: Class III
Status: Terminated
Initiated: 2019-12-13
Terminated: 2020-10-02
Firm location: Crumlin (North), N/A, Ireland

Product description

Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml

Reason for recall

A transcription error has occurred for the Randox Lipase colorimetric value in Liquid Clinical Chemistry Control lot 1021 UE. The target and range are listed as 50 U/L (40 - 60) and should be 72U/L (58 - 86).

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