inforMED
MalfunctionLIM

GAMMA

Received Sep 18, 2000 · Event occurred Sep 8, 2000

Report MW1019993 · MDR key 297548

Device

Generic name

*

Manufacturer

Gamma

Model number

*

Catalog number

*

Lot number

0829

Product problems

  • False Negative Result
  • Replace

Patient

*

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

GAMMA FETAL BLEED SCREENING TEST FOR THE DETECTION OF D-POSITIVE RED CELLS IN D-NEGATIVE MOTHERS AFTER DELIVERY. POSITIVE CONTROL DID NOT TEST POSITIVE. REPLACEMENT REAGENT SHIPPED.