Medical device manufacturer, BioMerieux, Inc., has initiated a medical device field safety correction action concerning Trepanostika TP recombinant with reference no.: 285034 and 285035. The affected lot numbers are D33GA, D33HA, D33KA, D33KB, D33KC, D33MA, D33N.
Following customer complaints on negative control out of range, bioMerieux investigation has confirmed an issue with some lots of Trepanostika TP recombinant and that the problem is due to the aluminum bag that contains the microelisa strip plates. The impacted strips may contain bad aluminum bags, or a mixture of good and bag aluminum bags. As a result, customers may either experience false results or negative control out of range. The investigation also determined that the 2 lots D33MA and D33NA also show a reduced sensitivity which may lead to obtain false nonreactive results.
The risk is considered as critical because false nonreactive results could lead to a non-reversible injury or illness to an individual or patient that requires immediate and/or major professional medical intervention.
The manufacturer advises users stop using and discard the affected product that they may have in stock. Also, the manufacturer advises users that for samples previously tested with the lots D33KA, D33KB, D33KC retest the samples having results with a ratio between 0.7 and 1.3. And for samples previously tested with the lots D33MA and D33NA retest all the nonreactive samples.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the affected product, please contact your supplier for necessary actions.
Posted on 8 March 2013