A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.There is no 510(k) for this device as it is manufactured outside the us and not sold in the us but is considered to be substantially similar to the legally u.S.Marketed device bd bbl¿ schaedler k-v agar with 5% sheep blood catalog number 221555 which has 510k number k760460.
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The following fields were updated due to additional information: h.7.Remedial action required: recall.H.9.Remedial action #: (b)(4).H.6.Investigation: this statement is to summarize findings on the recent complaint against plate schaedler agar / schaedler kv agar with 5% sheep blood (biplate) catalog number 254476, lot number 1104468.Event description: it was reported that some plates would show contaminaton on the medium.Complaint history review: the complaint trends were reviewed for a period covering 12 months.For this product, several complaints were reported for contamination issues.Therefore, a trend was identified, and further investigation was performed.Batch history record (bhr) review: the batch history review was performed.As part of the investigation, the ingredients of this medium were reviewed.During this review, no deviation was detected.Sample analysis: picture sample was provided for evaluation.Based on the picture, the schaedler agar side was found to be contaminated.Retain samples were reviewed for this lot.During this review, contamination could be detected.Evaluation results: at this stage of our investigation, we have excluded any systemic failure in our manufacturing process.A material review board (mrb) was conducted which led to a situation analysis (sa) which eventually resulted in a recall.The performed investigation showed that the origin of the contamination was associated with an anaerobic microorganism growing at lower temperatures (<22°c).This microorganism was detected for the first time at the production site.Therefore, and as no contamination complaints were received in conjunction with the respective product within the past year this event was concluded to be a single incident.However, regarding the reported contamination, please note that 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.Investigation conclusion: based on the evaluation of the report the complaint is confirmed.An mrb was initiated and a sa was performed for contamination issue, which led to a recall.We would suggest to set aside, and not use, any prepared plated media that does not meet the appearance specification as it is described on the bd certificate of analysis.This is consistent with industry recommendations for inspection of culture media prior to use (e.G.¿good practices for pharmaceutical microbiology laboratories¿, who technical report series, no.961, 2011, annex 2; chapter <1117> ¿microbiology best laboratory practices¿ the united states pharmacopeia; and the difco & bbl manual).H3 other text : see h.10.
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