TINA-QUANT HAPTOGLOBIN VER.2
Received Jul 1, 2026 · Event occurred Jun 5, 2026
Report 1823260-2026-02622 · MDR key 25676493
Device
Generic name
Haptoglobin, Antigen, Antiserum, Control
Manufacturer
Roche DiagnosticsCatalog number
08106045190
Lot number
88577601
Product problems
- Low Test Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE C503 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR TINA-QUANT HAPTOGLOBIN VER.2 (HAPT2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 5.80 G/L WITH A DATA FLAG. THE REPEAT RESULT WAS >5.82 G/L WITH A DATA FLAG. THE REPEATED RESULT WITH A 1:3 DILUTION WAS 0.0388 G/L. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 1.83 G/L WITH A DATA FLAG. A 1:3 MANUAL DILUTION WAS PERFORMED WITH A CALCULATED RESULT OF 5.49 G/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTS A SAMPLE-SPECIFIC INTERFERENCE.