TINA-QUANT C-REACTIVE PROTEIN IV
Received Jun 12, 2026 · Event occurred May 20, 2026
Report 1823260-2026-02335 · MDR key 25487893
Device
Generic name
C-reactive Protein Test System
Manufacturer
Roche DiagnosticsCatalog number
08057591190
Lot number
92637901
Product problems
- Low Test Results
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 3.74 MG/DL. THE RESULT WAS QUESTIONED BECAUSE IT DID NOT ALIGN WITH ANOTHER RESULT THAT WAS OBTAINED ON ANOTHER INSTRUMENT (RESULT WAS NOT PROVIDED). THE SAMPLE WAS REPEATED, AND THE REPEATED RESULT WAS 9.14 MG/DL. THE SAMPLE WAS REPEATED USING A MICROCUP, AND THE RESULTS WERE 12.2. MG/DL AND 12.2 MG/DL.