FDA-Device2023-09-27Class II
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Randox Laboratories Ltd.
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.
Sold states
US States: GA, OH, OR, PA, TX, VA
Affected count
66 kits
Manufactured in
55 Diamond Road, Crumlin (North), Ireland
Products
Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2609-2023Don't want to check this manually?
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