STA LIATEST D-DI
Received Oct 3, 2025 · Event occurred Sep 24, 2025
Report MW5176883 · MDR key 23208649
Device
Generic name
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Manufacturer
Diagnostica Stago, Inc.Model number
00515Lot number
273275
Product problems
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
DIAGNOSTICA STAGO STA-LIATEST D-DI REAGENT TO TEST D-DIMER IS DOES NOT CORRELATE WITH PREVIOUS LOT. IT HAS A CONSISTENT BIAS OF GREATER THAN 20% FROM PREVIOUS LOT. A LETTER WAS RECEIVED FROM MANUFACTURER NOTING THE INCONSISTENCY BUT NO SOLUTION TO RESOLVE. THIS INCONSISTENCY COULD HAVE CONSEQUENTIAL ADVERSE AFFECTS IN PATIENT CARE. THE LOT NUMBER FOR THE AFFECTED LOT IS 273275. THERE HAVE BEEN MULTIPLE LOTS WITH THE SAME PREFIX NUMBER 273### THAT HAVE BEEN TESTED AND ARE SEEING THE SAME BIAS OF 20-30%. <50 UG/ML IS THE REFERENCE RANGE.