Recall of certain batches of Eurotrol haemoglobin controls due to microbial contamination (MDA/2019/005) 를 위한 안전성 경고 / 현장 안전성 서한

Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.

The manufacturer has informed the MHRA that due to microbial contamination of quality controls, users may get readings below the values assigned to the product.There is a risk of 2 possible situations occurring:a functional haemoglobin analyser wrongly failing its quality control (QC) test, resulting in a delay in results as the analyser cannot be used on patient samples
a faulty haemoglobin analyser is wrongfully passed during its quality control (QC) test, possibly leading to an incorrect treatment.The Eurotrol haemoglobin controls are intended for professional use in the verification of the precision and accuracy of haemoglobin analysers. The purpose of these quality controls is to check calibration and other performance related characteristics.The manufacturer has taken the action to remove the products from the market and provide alternative batches to prevent interrupted use of the products.