Health product recall

Liquid Assayed Chemistry Control Premium Plus

Last updated

Summary

Product
Liquid Assayed Chemistry Control Premium Plus
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Liquid Assayed Chemistry Control Premium Plus

1308UE

1308UE

Issue

Randox laboratories can confirm that there has been a transcription error in the instructions for use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3, LAE4215, lot 1308UE. For caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect. The target and range values are correct. The IFU has been updated and is available on www.randox.com. Incorrect IFU should be discarded and the updated IFU should be downloaded.

Recall Start Date: August 3, 2023

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies

Randox Laboratories Ltd.

Ardmore, 55 Diamond Road, Crumlin, Antrim, Great Britain, BT29 4QY

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-74126

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