Investigation summary:event description: the customer reported problems from time to time with contamination by a filamentous element on our agars.Complaint history review: complaint history was reviewed, and similar complaints were identified for this catalog number.However, no trend was identified.Batch history record (bhr) review: the batch history record could not be reviewed, because there was no specific lot number.Sample analysis: retain samples could not be reviewed, because there was no specific lot number.Neither picture nor return samples were provided.Evaluation results: after investigations, no deviation could be detected in our validated manufacturing process.Since neither a specific lot number, nor pictures or returns were provided, no further investigations could be performed.Investigation conclusion: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.This product does not have an sal (sterility assurance level) claim.It is filled aseptically; therefore, an occurrence of a contamination event cannot be entirely ruled out.Please note that the valid standard for these products is din en 12322 "in vitro diagnostic medical devices - culture media for microbiology".According to this standard the contamination rate for each product lot must not exceed 4.9%.Based upon our continuous monitoring, we derive a contamination rate that falls below this specified value.According to our high-quality standard, we only release product batches to the market with an aql (acceptable quality level) = 0,65.Although this contamination level is very low, we cannot completely exclude that a customer may receive contaminated plates.Based on the above-mentioned evaluation, the complaint cannot be confirmed.Bd regrets the inconveniences you experienced and will continue to monitor similar incoming complaints.
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