Alkaline Phosphatase acc to IFCC Gen2 3333752190Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04015630919512), received between Feb 22, 2022 and Jul 26, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 AND UREAL UREA/BUN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THIS MEDWATCH WILL COVER ALP2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER PT-00070199 FOR INFORMATION ON THE UREA RESULTS. FOR SAMPLE 1, THE INITIAL ALP RESULT WAS 9 U/L. THE RESULT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 144 U/L. FOR SAMPLE 2, THE INITIAL UREA RESULT WAS 0.5 MMOL/L. THE RESULT WAS LOWER THAN THE MEASURING RANGE WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE REPEAT RESULT WAS 11.6 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840717 ↗
• MalfunctionJan 19, 2024Chemical Problem; Material Integrity Problem; Non Reproducible Results; Chemical Problem; Material Integrity Problem; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 6000 C501 MODULE. THE INITIAL ALP2 RESULT WAS <3 IU/ML. THE SAMPLE WAS REPEATED AND THE SAME RESULT WAS OBTAINED. A NEW SAMPLE WAS COLLECTED THE NEXT DAY AND THE RESULT WAS 155 IU/ML. THE RESULT OF 155 IU/ML WAS DEEMED CORRECT AS IT MATCHED THE PATIENT'S PREVIOUS RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18544472 ↗
• MalfunctionSep 25, 2023High Test Results; Material Integrity Problem; High Test Results; Material Integrity Problem

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 4 PATIENTS' SAMPLES TESTED WITH ALKALINE PHOSPHATASE GEN.2 (ALP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1: INITIAL RESULT: 275 U/L. RERUN RESULT: 74.14 U/L. SAMPLE 2: INITIAL RESULT: 265 U/L. RERUN RESULT: 67.98 U/L. SAMPLE 3: INITIAL RESULT: 308 U/L. RERUN RESULT: 80.26 U/L. SAMPLE 4: INITIAL RESULT: 250 U/L. RERUN RESULT: 64.58 U/L. THE PHYSICIAN QUESTIONED THE RESULTS AND THE SAMPLES WERE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17806551 ↗
• MalfunctionSep 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results

  HOLD PN 9/11. WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' PLASMA SAMPLES TESTED WITH ALKALINE PHOSPHATASE GEN.2 (ALP2) ASSAY ON A COBAS INTEGRA 400 PLUS ANALYZER. SAMPLE 1 (PATIENT 1): INITIAL RESULT: 15 U/L. 1ST REPEAT RESULT: 67 U/L. 2ND REPEAT RESULT: 425 U/L. SAMPLE 2 (PATIENT 2): INITIAL RESULT: 15 U/L. 1ST REPEAT RESULT: 392 U/L. THE PHYSICIAN QUESTIONED THE RESULTS. THE SAMPLES WERE THEN REPEATED. THE RESULTS OF 425 U/L FOR SAMPLE 1 AND 392 U/L FOR SAMPLE 2 WERE DEEMED TO BE CORRECT BASED ON THE PATIENTS' PREVIOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17719128 ↗
• MalfunctionNov 10, 2022Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL ALP2 RESULT WAS 337 U/L. THE REPEAT RESULT WAS 182 U/L. THE SAMPLE WAS REPEATED AGAIN ON ANOTHER ANALYZER AND THE RESULT WAS 190 U/L. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER IS 654864 AND THE EXPIRATION DATE IS 31-MAY-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15770603 ↗
• MalfunctionFeb 22, 2022High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT TESTED FOR ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) ON A COBAS INTEGRA 400 PLUS. THE INITIAL RESULT WAS 359.4 U/L. THE REPEAT RESULT WAS 214.2 U/L. THESE RESULTS DID NOT MATCH THE PREVIOUS ALP2 RESULT FROM THE PATIENT OF 77 U/L FROM (B)(6) 2022. THE CUSTOMER PERFORMED PRECISION TESTING WITH THE SAMPLE AND OBTAINED RESULTS BETWEEN 86.7 U/L AND 178.3 U/L. THE SAMPLE WAS REPEATED ON A DIFFERENT INTEGRA 400 PLUS WITH RESULTS OF 77.9 U/L, 75.7 U/L, 77.3 U/L AND 74.9 U/L. A 2ND SAMPLE WAS OBTAINED AND THE RESULTS WERE 124.7 U/L, 76.6 U/L, 83.4 U/L AND 74.6 U/L AND 76.2 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE INTEGRA 400 PLUS SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13580140 ↗