Public recall detail

Liquid Assayed Chemistry Control Premium Plus

2023-08-17

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Recall Safety notice
Quick summary

Quick summary: Liquid Assayed Chemistry Control Premium Plus. Date: 2023-08-17.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Liquid Assayed Chemistry Control Premium Plus. Date: 2023-08-17.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandRandox Laboratories Ltd.
ProductLiquid Assayed Chemistry Control Premium Plus
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-74126

Affected products

ProductLiquid Assayed Chemistry Control Premium Plus
Lot1308UE
Model1308UE
Serial number1308UE
DescriptionLiquid Assayed Chemistry Control Premium Plus

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

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Chemistry
CompaniesRandox Laboratories Ltd. Ardmore, 55 Diamond Road, Crumlin, Antrim, Great Britain, BT29 4QY
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-74126
Background{}
CompaniesRandox Laboratories Ltd. Ardmore, 55 Diamond Road, Crumlin, Antrim, Great Britain, BT29 4QY
AudiencesHealthcare
Source updated2023-08-17

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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