ALTP GEN.2
Received Jan 12, 2026 · Event occurred Dec 22, 2025
Report 1823260-2026-00141 · MDR key 24038856
Device
Product problems
- No Device Output
- Non Reproducible Results
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE CUSTOMER HAS PROVIDED ALT DATA FOR SUBSEQUENT SAMPLES COLLECTED FROM THE SAME PATIENT AS FOLLOWS: 0.13 KAT/L ON (B)(6) 2025, 0.20 KAT/L ON (B)(6) 2026, 0.17 KAT/L ON (B)(6) 2026, 0.15 KAT/L ON (B)(6) 2026, 0.12 KAT/L ON (B)(6) 2026, 0.14 KAT/L ON (B)(6) 2026, 0.10 KAT/L ON (B)(6) 2026, 0.12 KAT/L ON (B)(6) 2026, 0.12 KAT/L ON (B)(6) 2026,
Description of Event or Problem
THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR A SAMPLE FROM ONE PATIENT SAMPLE TESTED WITH ALTP GEN.2 ON A COBAS PURE C 303 ANALYTICAL UNIT. IT IS SUSPECTED THAT THE SAMPLE CONTAINS AN INTERFERING FACTOR WHICH CAUSES A LOW ALT RESULT. THE SAMPLE INITIALLY RESULTED IN AN ALT VALUE BELOW THE MEASURING RANGE OF THE ASSAY AND IT WAS ACCOMPANIED BY A DATA FLAG. NO SPECIFIC VALUE WAS PROVIDED FOR THE INITIAL RESULT. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF - 0.0476 UKAT/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED MULTIPLE TIMES ON THE C 303 SYSTEM; NO ADDITIONAL VALUES WERE PROVIDED. A SECOND SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND TESTED ON A COBAS C 703 UNIT. THE SAME ISSUE WAS OBSERVED. NO SPECIFIC RESULTS WERE PROVIDED. THE COBAS C 703 SYSTEM IS NOT SOLD IN THE UNITED STATES, NOR IS IT LIKE OR SIMILAR TO A PRODUCT SOLD IN THE UNITED STATES.
Additional Manufacturer Narrative
THE SERIAL NUMBER OF THE C 303 ANALYZER IS (B)(6). THE SERIAL NUMBER OF THE C 703 ANALYZER WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.