Alanine Aminotransferase / Aspartate Aminotransferase acc. to IFCC with PYP 5531462190Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04015630927425), received between Dec 2, 2022 and Dec 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unable to Obtain Readings” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2022Unable to Obtain Readings; Unable to Obtain Readings

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS ACCOMPANIED BY DATA FLAGS FOR ONE PATIENT SAMPLE TESTED WITH THE ALTPM-ALANINE AMINOTRANSFERASE ASSAY ON A COBAS 8000 C702 MODULE, SERIAL NUMBER (B)(4). THE SAMPLE INITIALLY RESULTED IN A VALUE OF 56.6 U/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED RESULTING IN A VALUE OF 58.1 U/L, ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED ON A SECOND C702 ANALYZER, RESULTING IN AN UNKNOWN VALUE, ACCOMPANIED BY A DATA FLAG. THE ASSAY WAS PERFORMED ON HEPARINIZED PLASMA OUT OF THE PRIMARY TUBE. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. AN INTERFERENCE IS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15907053 ↗