FDA-Device2023-07-05Class III
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Randox Laboratories Ltd.
Hazard
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch 583135 lot 2031EC has been reassigned on the Roche Cobas e801 due to High recovery outside range
Sold states
CA, IL, VA, WA, WI including PR
Affected count
1 kit
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of analytes. Catalog Number: IA2640
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2021-2023Don't want to check this manually?
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