Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-1100-2020

December 13, 2019

Class III

Product summary

Firm
Randox Laboratories Ltd.
Event
Event 84547
Status
Terminated
Classification
Class III
Quantity
2
Official record key
device-enforcement:Z-1100-2020

Official wording

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).

Code information: Catalogue Number: LAE4217 GTIN: 05055273208993 Lot Number: 1021UE (EXP: 2020-06-28)

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).