medical Class II Updated 2023-09-27

Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catal

Recalled Product

Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Hazard / Issue

there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.

Issued by

FDA

Affected States: GA, OH, OR, PA, TX, VA
Lot/Code Info: UDI-DI: 05055273208986; Lot Number: 1308UE
View official government recall

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