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Health Canada Medical devices

Liquid Assayed Chemistry Control Premium Plus

Issued August 17, 2023
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
Hazard description
Labelling and packaging
Product
Product name
Liquid Assayed Chemistry Control Premium Plus
Reference
ID
RA-74126