inforMED
MalfunctionGHQ

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Received Dec 10, 2002

Report MW4003423 · MDR key 435627

Device

Generic name

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Manufacturer

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Model number

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Catalog number

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Lot number

92549

Product problems

  • Mislabeled

Patient

NA

Narrative

Description of Event or Problem

MISLABELED KLEINHAUER-BETKE STAIN (FETAL HEMOGLOBIN STAIN KIT). LOTS INVOLVED 92549 AND 92558. LOT 92549 HAS ALL BOTTLES IN LOT ARE LABELED AS FIXING SOLUTION WHEN ACTUALLY HALF THE BOTTLES ARE BUFFER SOLUTION. LOT 92558 HAS ALL BOTTLES LABELED AS BUFFER SOLUTION WHEN IN FACT, HALF THE BOTTLES ARE FIXING SOLUTION.