Catalog Number 254089 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/04/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1076973.Medical device expiration date: 2021-06-14.Device manufacture date: 2021-03-17.Medical device lot #: 1069887.Medical device expiration date: 2021-06-08.Device manufacture date: 2021-03-10.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¿ gc ii agar with isovitalex¿ enrichment catalog number 221240 which has 510k number k945569.
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Event Description
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It was reported that while using 171 plate choco gc agar w/isovitalex 90mm a missing label was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the plates are completely without a label.Since the boxes are already gone, it is not possible to verify whether it is batch 1076973 or 1069887.".
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Manufacturer Narrative
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Investigation summary: it was reported that the plates would be completely without a label.In this case, it was not possible to verify whether it is batch 1076973 or 1069887.The complaints trends were reviewed for a period covering 12 months.There was one similar complaint received during that period of time on this product.The batch history review did not indicate any discrepancies.All release testing was satisfactory, and no deviations were observed.Picture sample was provided showing partially printed plates and one plate without any bottom print.The retain samples were reviewed and it was detected that several batch numbers were affected.Further investigation was performed and documented within capa 2793743.Based on the evaluation of the report the complaint was confirmed.
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Event Description
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It was reported that while using 171 plate choco gc agar w/isovitalex 90mm a missing label was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the plates are completely without a label.Since the boxes are already gone, it is not possible to verify whether it is batch 1076973 or 1069887.".
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Search Alerts/Recalls
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