FDA-Device2020-02-12Class III
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Randox Laboratories Ltd.
Hazard
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).
Sold states
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.
Affected count
2
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1100-2020Don't want to check this manually?
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