FDA-Device2019-08-14Class II
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Randox Laboratories, Limited
Hazard
The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.
Sold states
US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.
Affected count
149 (US)
Manufactured in
Ardmore; 55 The Diamond Road, N/A, Crumlin, N/A, United Kingdom
Products
Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2150-2019Don't want to check this manually?
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