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¿ columbia cna agar with 5% sheep blood catalog number 221353 with 510k number preamendment.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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H6: investigation summary: it was reported that 35 plates would have show contamination.The complaint trends were reviewed and similar complaints were found for this lot number.Therefore, a mrb (material review board) was performed and the results were documented within a cid (corrective and preventive action initiation determination).The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Pictures were provided showing the reported contamination.The retention samples were reviewed and one plate with contamination was detected.At this stage of our investigation, we have excluded any systemic failure in our manufacturing process.Please note that this product does not have an sal claim.It is filled aseptically, therefore an occurrence of a contamination event cannot be entirely ruled out.We only release product batches to the market with an aql (acceptable quality level) = 1.5.Although this contamination level is very low, we cannot completely exclude that a customer may receive a contaminated plate.As several complaints were reported for this product lot number regarding contamination, further evaluation will be conducted via cid.As a root cause it could be identified that the blood pool which was used during a timely isolated production frame was contaminated.The contaminant which was also identified on one plate in the retain samples, is easy detectable as it grows before incubation.Based upon our investigation the complaint was confirmed.H3 other text : see h10.
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