MalfunctionJHG
FETAL LUNG MATURITY ASSAY
Received Feb 14, 1995
Report MW1005133 · MDR key 19724
Device
Manufacturer
Abbott LaboratoriesProduct problems
- False Reading From Device Non-Compliance
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
FETAL LUNG MATURITY ASSAY FAILS TO RECOVER CONTROL RESULTS WITHIN ACCEPTABLE RANGES. THE PROBLEM APPEARS TO BE SOMEHOW RELATED TO THE LOT NOS OF STANDARDS AND CONTROLS IN USE. MFR'S TECHNICAL SERVICE HAS BEEN CONTACTED NUMEROUS TIME (BEGINNING OF 12/94 FIRST CALL WAS MADE) WITH NO IMMEDIATE ACTION TO CORRECT THE PROBLEM.