FDAClass IIIFebruary 12, 2020

Liquid Clinical Chemistry Control recall

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

Why was Liquid Clinical Chemistry Control recalled?

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).

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Liquid Clinical Chemistry Control, Catalogue Number: LAE4217, Size: 12 x 5 ml
Recalling firm
Randox Laboratories Ltd.
Quantity
2
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.
Recall date
February 12, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls