Alanine Aminotransferase acc. to IFCC with pyridoxal phosphate activation 4467388190Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04015630920532), received between Aug 29, 2018 and Aug 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Non Reproducible Results

  There was an allegation of questionable Creatinine plus ver.2 and ALTP results for 4 patient samples on a cobas 4000 c311 stand alone system. This Medwatch will cover ALT. Refer to Medwatch with A1 patient identifier (b)(6) for information on the creatinine results.On (b)(6) 2026, sample 1 had an initial creatinine result of 2.27 mg/dL.The customer questioned the result as it did not match the patient's clinical history which prompted them to repeat the sample.The repeat result was 0.82 mg/dL.No questionable results were reported outside of the laboratory.On (b)(6) 2026, sample 2 had an initial creatinine result of 7.41 mg/dL.The repeat result was 0.56 mg/dL.On (b)(6) 2026, sample 3 had an initial creatinine result of 3.21 mg/dL.The repeat result was 1.03 mg/dL.On (b)(6) 2026, sample 4 had an initial ALT result of 584.1 U/L.The repeat result was 19.4 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50199917 ↗
• MalfunctionAug 29, 2018Low Test Results; Low Test Results

  THE CUSTOMER ORIGINALLY COMPLAINED ABOUT QUESTIONABLE CREP2 CREATININE PLUS VER.2 TESTED ON BOTH A COBAS 6000 C (501) MODULE AND A COBAS 8000 (UNSPECIFIED MODULE) COMPARED TO AN ABBOTT SYSTEM. FROM THE DATA PROVIDED, A REPORTABLE MALFUNCTION WAS PROVIDED FOR CREP2, ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, ALTLP ALANINE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION, AND GGT-2 -GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ. THIS MEDWATCH WILL COVER ALTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON CREP2. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE THE INITIAL HIGH CREP2 RESULT, BUT THERE WAS NO ALLEGATION THAT THE PATIENT WAS ADVERSELY AFFECTED. THE COBAS C501 SERIAL (B)(4). THE CUSTOMER DID NOT PROVIDE ANY SPECIFIC INFORMATION ON THE COBAS 8000 SYSTEM. A PRELIMINARY ASSESSMENT OF THE CASE STATED THAT BASED ON PREVIOUS ELECTROPHORESIS TESTING OF THE PATIENT, THE PATIENT IS BELIEVED TO HAVE AN INTERFERI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827930 ↗