TINA-QUANT IGG GEN.2
Received May 27, 2026 · Event occurred Apr 29, 2026
Report 1823260-2026-02082 · MDR key 25303433
Device
Generic name
Igg, Antigen, Antiserum, Control
Manufacturer
Roche DiagnosticsCatalog number
08057915190
Lot number
909414
Product problems
- Output Problem
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE REAGENT LOT NUMBER IS 909414. THE INVESTIGATION IS ONGOING.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE TINA-QUANT IGG GEN.2 RESULT FOR A PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 62.2 G/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS REPEATED WITH AUTOMATIC DILUTION, YIELDING A RESULT OF 63.5 G/L. THE DOCTOR QUESTIONED THE RESULT, WHICH TRIGGERED A RERUN ON (B)(6) 2026. THE REPEAT RESULT WAS 11.7 G/L. AFTER 1:5 DILUTION, THE REPEAT RESULT WAS 11.6 G/L. THE REPEAT RESULT OF 11.7 G/L WAS DEEMED CORRECT AND REPORTED OUT.