Almost 300 babies may have wrong blood groups, says HSE
Potentially mislabelled test kits used in five hospitals
The HSE said last night that the risk of a baby’s blood group test result being incorrect was “extremely low”. Photograph: Brenda Fitzsimons/The Irish Times
Almost 300 newborn babies may have been incorrectly blood-grouped at birth following revelations that potentially mislabelled test kits were used in five hospitals.
The HSE has insisted it is extremely unlikely anyone will have been affected by the error, and it has contacted all relevant parties.
As part of routine hospital procedure, babies’ blood types are tested at the time of delivery.
Ortho Clinical Diagnostics, which manufactures one of the kits used to do this - the Ortho BioVue System Cassette - revealed a small number of them issued worldwide may have been incorrectly labelled.
An error in the positioning of a label on the kit may indicate an inaccurate result.
Accordingly, the HSE contacted parents saying 278 children may have been wrongly grouped.
It also said there was a potential for 220 mothers to have received anti-D when they may not have needed it as a result of the faulty tests.
Anti-D is a medication commonly administered to mothers whose children have differing blood types.
A further 30 mothers may not have received anti-D when they did need it, while 12 babies may have received red blood cells when they did not need it.
Last night the HSE moved to quell concerns, stressing there was just a one in 11 million chance that a kit would be mislabelled.
Therefore, it said, the figures issued represent only an outside potential of mistakes having been made in Irish hospitals.
As an additional comfort, it said that regardless of inaccurate results it was standard policy for anyone attending hospital to be retested for their blood type.
“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,” it said in a statement.
“There are no immediate safety concerns, however, anyone affected can discuss the implications for them directly with their hospital.
“All patients, including babies, will always have a repeat blood group test when being admitted to any hospital or in pregnancy.”
The potential risk was alerted by the Irish Medicines Board (IMB), who notified the HSE that a “field safety notice” had been issued in relation to a “small number” of the products. This is a procedure that alerts hospitals to the possibility of a faulty product, but is not the same thing as a product recall.
“Five hospitals have been identified as having received the potentially affected test kits,” the HSE said.
“There is a small chance that babies who were tested using these kits may have been incorrectly blood typed.
“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.
“The manufacturer has estimated that the potential risk of a kit being labelled incorrectly is less than 1 in 11 million.”
Parents were alerted in line with standard procedure, but officials have insisted the risk is remote.
Each hospital has established a dedicated phone line for those affected, while contact details have been provided in the letters sent to those affected. They are also available from the HSE Information line on 1850 24 1850.