Randox Laboratories Ltd.: Medical Device Recall in 2019 - (Recall #: Z-1057-2019)

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:

Randox Blood Gas Control Level 2 -Model BG5002. In-vitro Diagnostic Quality control of Blood Gas analysis This product is intended for in vitro diagnostic use, in the quality control of Blood Gas analysis. Target values and ranges are supplied for the following analytes: Calcium, Chloride, Glucose, Lactate, PCO2, pH, pO2, Potassium, Sodium and Total CO2.

Product Classification:

Class II

Date Initiated: February 13, 2019

Date Posted: April 3, 2019

Recall Number: Z-1057-2019

Event ID: 82195

Reason for Recall:

An error in the assignment of the control range pH in Blood Gas Control

Status: Terminated

Product Quantity: 1 kit

Code Information:

Lot Code: 184BG GTIN: 05055273227116

Distribution Pattern:

US Distribution to state of: WV

Voluntary or Mandated:

Voluntary: Firm initiated