FDA-Device2019-04-17Class III
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Randox Laboratories Ltd.
Hazard
The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
Sold states
The products were distributed to the following US states: WV and Puerto Rico.
Affected count
58
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Immunoassay Premium Controls, Model Numbers IA2633 and IA2638 Product Usage: This product is intended for in vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes listed in the package insert
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1105-2019Don't want to check this manually?
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