GREINER BIO-ONE NA INC VACUETTE TUBE 4 ML K2E K2EDTA 13X75 LAVENDER CAP-BLACK RING, NON-RIDGED; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
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Model Number 454209CA |
Device Problems
Nonstandard Device (1420); Incorrect, Inadequate or Imprecise Result or Readings (1535)
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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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Gbo complaint: (b)(4).We received customer pictures and received 24rk and 375 loose tubes of item 454209ca/ lot b16013cw for evaluation.We have no further inventory of the material/batch.The complaint is confirmed.Recall was initiated.
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Event Description
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Customer states that some tubes contain liquid as opposed to spray-dried edta.This was discovered when the facility was troubleshooting erroneous average glomerular volume results on four different patients.The internal investigation at the facility found that the tubes containing liquid additive gave a hi her result, for a mean of 10 fl, on this parameter.
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Search Alerts/Recalls
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