GREINER BIO-ONE GMBH VACUETTE 3 ML VIRUS STABILIZATION TUBE 13X100 RED CAP-WHITE RING, PREMIUM; CULTURE MEDIA
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Model Number 456161 |
Device Problem
Component Missing (2306)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Complaint (b)(4).A date of the event could not be obtained from the customer.No samples were received.The provided photos were forwarded to the manufacturer, where we purchase they product from.As soon as the investigation of the alleged event is completed, a supplemental report will be filed.
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Event Description
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Customer states 8 tubes do not have pbs in them.They have not observed pbs leaking, so they believe they were never filled.Customer advises that the provided photos of these tubes had swabs added to the tubes before the discovery was made that no liquid was in them, so they cannot remove them from the bsl-2+ and therefore can not return tubes.They will watch for more empty tubes and send those if discovered.Unfortunately, it wasn't caught during the kit making process and was only caught after they came back post sampling.No liquid was found in the bags that were used to house the tubes and the swabs were completely dry.No observable liquid was found in the tubes or in the bag indicating that the tubes had no liquid in them.Customer advises there is no way to know at this time if the tubes were from the same rack or multiple racks.Customer advises the carton and rack label are now long gone.
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Manufacturer Narrative
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Received customer pictures.We have no further complaints on the material/batch.We have no further inventory of the material/batch.We forwarded the complaint and customer pictures to our affiliated headquarters in austria from which we receive this product.According to their investigation and comments, an intensive root cause analysis was conducted; however, a root cause for the reported claim could not be found.Currently, there are no complaints on the reported mishap.The complaint cannot be determined.Corrected data: h6: type of investigation, investigation conclusion; h10: manufacturer narrative.
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Search Alerts/Recalls
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