FDA recall Z-2150-2019

Randox Laboratories, Limited · Class II · device

Product

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.

Reason for recall

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.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-06-11
Report date
2019-08-14
Termination date
2020-05-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Crumlin, N/A, United Kingdom

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2150-2019