gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04015630916511), received between Aug 29, 2018 and Oct 7, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

1 other recall cover devices cleared under the same FDA submission (K972250); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 7, 2024Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GGT-2 ¿-GLUTAMYLTRANSFERASE VER.2 STANDARDIZED AGAINST IFCC / SZASZ RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL GGT-2 RESULT WAS 4 U/L. THE SAMPLE WAS REPEATED AND THE RESULT WAS 26 U/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20384249 ↗
• MalfunctionMar 7, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR THREE PATIENT SAMPLES TESTED ON A COBAS 6000 C (501) MODULE. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. RESULTS FOR THE FOLLOWING ASSAYS WERE AFFECTED: ISE INDIRECT NA, K, CI FOR GEN.2 AND ASTLP ASPARTATE AMINOTRANSFERASE ACC. TO IFCC WITH PYRIDOXAL PHOSPHATE ACTIVATION. THE COMPLAINED SAMPLE FROM THE FIRST PATIENT RESULTED IN THE FOLLOWING VALUES: NA RESULTS = 123 MMOL/L WITH A DATA FLAG ON (B)(6)2023; 141 MMOL/L, 142 MMOL/L, 143 MMOL/L, AND 143 MMOL/L ON (B)(6)2023; 144 MMOL/L AND 143 MMOL/L ON 07-FEB-2023. K RESULTS = 3.68 MMOL/L ON (B)(6)2023; 4.33 MMOL/L AND 4.29 MMOL/L ON (B)(6)2023 ; 4.31 MMOL/L AND 4.28 MMOL/L ON 07-FEB-2023. CL RESULTS = 90.6 MMOL/L WITH A DATA FLAG ON 05-FEB-2023; 106 MMOL/L, 104.3 MMOL/L, 104.8 MMOL/L, AND 105.2 MMOL/L ON (B)(6)2023; 104.7 MMOL/L AND 104.3 MMOL/L ON (B)(6)2023. THE SAMPLE PROBE WAS CHANGED AND QUESTIONABLE RESULTS WERE THEN OBSERVED FOR THE REMAINING SAMPLES. THE COMPLAINED SAMPLE FROM THE SECOND PATIENT RESULTED IN THE FOLLOWING VALUES: NA RESULTS = 128 MMOL/L WITH A DATA FLAG AND 138 MMOL/L ON (B)(6)2023. CL RESULTS = 96.3 MMOL/L WITH A DATA FLAG,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496361 ↗
• MalfunctionAug 29, 2018High Test Results; High 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 GGT-2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ASTLP. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON CREP2. PLEASE REFER TO THE MEDWATCH WITH (B)(6) FOR INFORMATION ON ALTLP. THE ERRONEOUS RESULTS WERE RELEASED OUTSIDE OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL DUE TO 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 INTERF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7827934 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972250. One submission often covers many models, so check the product and lot details in each record.

• Z-0688-2008 · Dec 3, 2007 · Terminated
  Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250