Model Number 442020 |
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 03/11/2022 |
Event Type
malfunction
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Event Description
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It has been reported that the bd bactec¿ peds plus¿/ f culture vials (plastic) has been found with no label.The following has been provided by the initial reporter: this is a report about a labeling issue.According to the customer's report, the japanese language label which should have been affixed was missing upon arrival.
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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.
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Event Description
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It has been reported that the bd bactec¿ peds plus¿/ f culture vials (plastic) has been found with no label.The following has been provided by the initial reporter: this is a report about a labeling issue.According to the customer's report, the japanese language label which should have been affixed was missing upon arrival.
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Manufacturer Narrative
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After further review mfr.Report # 2647876-2022-00084 is no longer reportable.Verified with qe this is not a product issue.The japanese language label is applied in japan.This is a distribution center/shipping issue.As a result mfr.Report # 2647876-2022-00084 is null and void.
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Search Alerts/Recalls
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