Randox Laboratories Ltd.: Medical Device Recall in 2020 - (Recall #: Z-1547-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Chemistry QC Premium Plus, Cat. No. LAL4213, GTIN 05055273209006 - Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The device is for the control of accuracy.

Product Classification:

Class II

Date Initiated: February 18, 2020

Date Posted: April 1, 2020

Recall Number: Z-1547-2020

Event ID: 85030

Reason for Recall:

The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

Status: Ongoing

Product Quantity: 186 total, 27 USA

Code Information:

Lot 306UL

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of WV, IN, VA, ID, PR, DE, and countries of West Indies, Czech Republic, France, Germany, Hong Kong, Ireland, Italy, Norway, Philippines, South Africa, South Korea, Sweden, Taiwan (R.O.C.), Thailand, UAE, UK.

Voluntary or Mandated:

Voluntary: Firm initiated