Model Number 454297 |
Device Problem
Therapeutic or Diagnostic Output Failure (3023)
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Patient Problem
Insufficient Information (4580)
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Event Type
malfunction
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Manufacturer Narrative
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Complaint (b)(4).Dates of event could not be obtained form the customer.Samples were received and forwarded for investigation to the manufacturer, where we purchase the product from.As soon as the investigation is completed, a supplemental report will be filed.
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Event Description
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Customer states having problem with the tubes and extra anticoagulant powder not mixing with the blood specimen.Often the gray powder floats at the top of the tube even after multiple inversions and centrifugation.All tubes are affected.Customer advises they always mix appropriately.Once they centrifuge there is still some powder that is not absorbed.No photos available but will try to get pictures of issue.
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Manufacturer Narrative
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Received 1rk 454297/a200536p for evaluation.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint and customer samples to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, a review of the production records revealed no deviations which could be linked to the reported error.Samples were examined.The measured parameters of the draw volume and the amount of additive were within tolerance.The solubility of the powder was checked and after two minutes of inversion of samples, the powder was visibly dissolved in water.Therefore, the complaint is not confirmed.
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Search Alerts/Recalls
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