Randox Laboratories, Limited: Medical Device Recall in 2019 - (Recall #: Z-2150-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 11, 2019

Date Posted: August 14, 2019

Recall Number: Z-2150-2019

Event ID: 83155

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.

Status: Terminated

Product Quantity: 149 (US)

Code Information:

1306UN, 1308UN, 1309UN

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated