Around 220 new mums in five hospitals were reportedly given the anti-D blood product, though they may not have needed it.

It's due to a labelling error, which is also understood to have resulted in nearly 280 newborns being labelled with the wrong blood group.

According to reports, some 12 infants may also have been given unnecessary blood transfusions.

It's alleged to have happened at the Rotunda in Dublin as well as at hospitals in Cavan, Sligo, Limerick and Galway.

HSE statement

The Health Service Executive issued a statement last night, providing background information.

As part of routine hospital procedures, a baby’s blood group is checked at the time of delivery. One of the blood group test kits used for this is the Ortho BioVue System Cassette (manufactured by Ortho Clinical Diagnostics, a Johnson and Johnson company).

The HSE was recently notified by the Irish Medicines Board that a Field Safety Notice had been issued as a small number of the testing kits supplied worldwide had been incorrectly labelled.

This means that there is a small chance that the results of some blood group tests may have been incorrectly reported in some cases. The manufacturer has estimated that the potential risk of a kit being labelled incorrectly is less than 1 in 11 million.

As part of the response to this, every hospital that used these type of kits has completed an inspection of the remaining kits in stock and has removed any potentially affected batches. Each hospital has also conducted a review of the results of the testing done using these kits in each hospital.

Five hospitals have been identified as having received the potentially affected test kits. There is a small chance that babies who were tested using these kits may have been incorrectly blood typed.

Each of these hospitals began contacting affected mothers on Monday, August 12th. Letters have been sent to anyone potentially affected by this manufacturing error.
The risk of a baby’s blood group test result being incorrect is extremely low as the manufacturing error related to a label being incorrectly affixed to the test kit.

There are no immediate safety concerns however anyone affected can discuss the implications for them directly with their hospital. Each hospital has in place a dedicated phoneline for those affected - contact details have been provided in the letters sent to those affected or are available from the HSE Information line 1850 24 1850.

All patients, including babies, will always have a repeat blood group test when being admitted to any hospital or in pregnancy.