inforMED
OtherKSO

ID-MTS READER SA

Received Oct 30, 2003

Report 1058138-2003-00009 · MDR key 494162

Device

Generic name

Blood Grouping Centrifuge And Reader

Model number

MTS9945

Catalog number

MTS READER SA

Lot number

*

Product problems

  • False Positive Result

Patient

NA

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE REACTIVITY (1+) WITH THE MTS READER SA WITH MULTIPLE MICROTUBES IN CARDS SHOWING NEGATIVE REACTIONS. NO DEATH OR SERIOUS INJURY WAS ASSOCIATED WITH THIS INCIDENT.

Remedial action

  • Other