A lot of media administered in IVF/ART are holding the antibiotic Gentamicin.
Recently a manufacturer of Gentamicin Sulfate released batches with elevated levels of histamine which then were used by various IVF manufacturers to produce final products. The respective batches have been recalled by the MHRA (UK) and a so called “Medical Device Alert” has been announced.
We reconciled the announced batches with those used in the production of our media. None of the affected batches has been used in the production of the Gynemed Media Line. This has been reported to the MHRA and has been approved by them.