FDA-Device2016-10-12Class II
IgE Calibrator Series
Randox Laboratories Ltd.
Hazard
According to the firm, the IgE Calibrator Series IE2492 (lot 387-392IE) value assignment has now been aligned to the 3rd International Standard for human serum IgE 11/234. Turbidimetric (Non-IFCC Cal.) Quality Control Targets and Ranges now apply. The calibrator value sheet is to be updated with the new values.
Sold states
All consignees are in the US.
Affected count
4
Manufactured in
55 Diamond Road, N/A, Crumlin (North), N/A, Ireland
Products
IgE Calibrator Series
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0050-2017Don't want to check this manually?
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