Randox Laboratories Ltd.: Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US States: GA, OH, OR, PA, TX, VA Quantity: 66 kits Lot/code info: UDI-DI: 05055273208986; Lot Number: 1308UE

UPC codes

05055273208986

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.