FDA recall Z-1057-2019

Product

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.

Reason for recall

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

Distribution

US Distribution to state of: WV

Key facts

Status

Terminated

Initiation date

2019-02-13

Report date

2019-04-03

Termination date

2020-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Crumlin (North), N/A, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1057-2019