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Ortho BioVue Baby Blood Group Testing


14th August 2013

The HSE and the Rotunda Hospital have been notified recently by the manufacturer of our baby blood group tests (Ortho Clinical Diagnostics, a Johnson and Johnson company) that a very small number of the testing kits supplied worldwide have been incorrectly labelled.

This means that there is a small chance that the results of some baby blood group tests may have been incorrectly reported.  The manufacturer has estimated that the potential risk of a kit being labelled incorrectly is less than 1 in 11 million.  To date, no mislabelled kits have been discovered in Ireland.  The kits were used in the Rotunda between February 27th 2013 and June 23rd 2013. 

The hospital has completed an inspection of the remaining kits in stock and has removed any potentially affected batches.  The hospital has also conducted a review of the results of the testing done using these kits in our hospital.

The possible errors are:

·       Baby’s blood group result may have been reported incorrectly;
·       Baby may have received RhD positive red blood cells instead of RhD negative red blood cells;
·       Mother did not get Anti-D when she may have required it; or
·       Mother may have received Anti-D unnecessarily.

We have written to the women concerned and informed them of the possible error that relates to them.  They also received a question and answer leaflet relevant to the issue that concerns them.  We would like to reassure women and their families that the likelihood of an error is extremely low (less than 1 in 11 million).  We have established a Helpline for women concerned to contact us if they have any queries.  The number is 1800 855 761 and the Helpline is open between 9.00am and 4.00pm Monday to Friday.

Please click here to see some questions and answers about blood groups.


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