Investigation summary: during manufacturing of material 221267, media is formulated and sent through a high temperature short time sterilizer to remove bioburden.The petri dishes are subjected to uv radiation to decrease bioburden.The petri dishes are filled in a positive pressure hepa filtered environment.The filled plates are cooled and immediately wrapped into sleeves to decrease the introduction of microbes.Sleeves are then packaged into cartons and then transferred to a refrigerated truck (2 to 8 degrees c) for shipment to the distributor.Bd distributors are provided with the storage guidelines for the shipping and handling of bd media of 2 to 8 degrees c in a dark place.The batch history record for batches 0281098, 0260862, 0226666 and 0212671 were satisfactory at time of release and no quality notifications were generated during manufacturing and inspection.All batches are tested prior to release and results reported on the certificate of analysis.Chocolate ii agar is stability tested annually for biological performance to ensure satisfactory performance throughout shelf life with the organisms that are reported on the certificate of analysis.All performance testing on the batches in question were satisfactory at the time of release.The complaint history was reviewed and no other complaints have been taken on batches 0281098, 0260862, 0226666 and 0212671 for performance.Retention samples from batches 0281098, 0260862, 0226666 and 0212671 were not available for inspection.Customer test data was received.The data describes organisms tested on batch 0281098 where the growth on batch 0281098 was not as good when compared to growth on other media.Four photos also were received for investigation.Each photo is a collage of two plates, one chocolate brown agar plate and one medium red agar plate.Each photo shows the agar surface of the two plates with streak lines visible on each plate and each medium red agar plate has more growth than the chocolate brown agar plate (described as a plate from batch 0281098).It is followed that the photos are showing the chocolate agar has less growth as compared to the other media used.However, this investigation cannot make conclusions about performance from photos alone.Returns were not received for investigation.No other complaints were taken for performance from the batches in question and review of the batch history records were satisfactory.It is noted that batches 022666 and 0212671 expired on 2020-12-08 and 2020-11-24, respectively.This complaint was taken on january 15, 2021.Bd makes no claims on expired products.This complaint cannot be confirmed for a performance defect on the batches in question.Bd will continue to trend complaints for performance.
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