FDA recall Z-1100-2020

Product

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).

Distribution

US: NY and DE OUS: France, Lithuania, Poland, Spain, Switzerland, Turkey, Australia, Hong Kong, Bosnia and Herzegovina, Costa Rica, Ecuador, Gambia, New Zealand and Solomon Islands.

Key facts

Status

Terminated

Initiation date

2019-12-13

Report date

2020-02-12

Termination date

2020-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2020