Alkaline Phosphatase acc to IFCC Gen2 3333701190Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04015630919505), received between Jul 11, 2022 and Jan 9, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE INITIAL RESULT WAS 130 U/L. THIS RESULT WAS QUESTIONED AS IT DID NOT COMPARE TO THE PREVIOUS DAY'S RESULT. THE REPEAT RESULTS FROM ANOTHER COBAS C501 ANALYZER WERE 94 U/L AND 83 U/L. THE REPEAT RESULT FROM THE ORIGINAL COBAS C501 ANALYZER WAS 84 U/L. THIS RESULT WAS BELIEVED TO BE CORRECT. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020155 ↗
• MalfunctionNov 26, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER ALP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CALCIUM RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LACTATE RESULTS, MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS, AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE AST RESULTS. THE DOCTOR QUESTIONED THE RESULTS AS THEY WERE HIGH AND DID NOT MATCH THE CLINICAL STATUS OF OUTPATIENTS IN "NORMAL" CONDITION. NO SPECIFIC SAMPLE RESULTS WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657165 ↗
• MalfunctionNov 4, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALP2 (ALP IFCC GEN.2) RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS AND AN UNSPECIFIED COBAS PRO ANALYZER. THE REPORTER STATED THEY WERE CROSS-CHECKING RESULTS FROM THE COBAS PRO WITH THE REPORTED COBAS INTEGRA. THEY FOUND RESULT REPEATABILITY ISSUES WHEN USING THE TUBE, BUT NOTED THE RESULTS WERE PRECISE WHEN "EPPENDORF" TUBES WERE USED. THE PATIENT SAMPLE WAS RUN 5 TIMES ON THE COBAS INTEGRA. THE RESULTS ARE: 157.07 U/L, 255.96 U/L, 151.79 U/L, 117.00 U/L, 93.91 U/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AS THEY DID NOT MATCH CLINICALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20601653 ↗
• MalfunctionApr 15, 2024Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ALP2 ALP IFCC GEN.2 (ALP2) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT FROM THE PRIMARY TUBE WAS 145 U/L. THE REPEAT WITH THE PRIMARY TUBE WAS 200 U/L. THE SECONDARY TUBE WAS RUN AFTER BEING CENTRIFUGED AND THE RESULT WAS 105 U/L. THE SECONDARY TUBE WAS REPEATED WITH A RESULT OF 105 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19106663 ↗
• MalfunctionNov 20, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. THIS MEDWATCH WILL COVER ALP2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE LDH RESULTS. ON (B)(6) 2023, SAMPLE 1 HAD AN INITIAL ALP RESULT OF 802 U/L. TH SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 467 U/L AND 364 U/L. ON (B)(6) 2023, THE INITIAL RESULT WAS 355.8 U/L. THE REPEAT RESULT WAS 143.9 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170482 ↗
• MalfunctionNov 17, 2023High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ALP2 (ALP IFCC GEN.2) ON A COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 177 UI/L. SINCE A PRIOR RESULT FOR THE PATIENT FROM (B)(6) 2023 WAS 88 UI/L THE CUSTOMER¿S LABORATORY INFORMATION SYSTEM (LIS) REQUESTED AN AUTOMATIC REPEAT AND THE RESULT WAS 119 UI/L. THE CUSTOMER REPEATED THE SAMPLE ON ANOTHER COBAS 6000 LINE AND THE RESULTS WERE 104 UI/L AND 94 UI/L. THESE RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18158760 ↗
• MalfunctionSep 1, 2023Incorrect Measurement; Incorrect Measurement

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) ON A COBAS 6000 C (501) MODULE. PATIENT 1 WAS TESTED 3 TIMES WITH RESULTS OF LESS THAN 5 U/L WITH A DATA FLAG. THESE RESULTS ARE IN QUESTION AS THE PATIENT IS KNOWN TO HAVE ALP2 RESULTS OF APPROXIMATELY 90 U/L.. ON (B)(6) 2023 PATIENT 2 WAS TESTED 3 TIMES WITH RESULTS OF LESS THAN 5 U/L WITH A DATA FLAG. THESE RESULTS ARE IN QUESTION AS THE PATIENT IS KNOWN TO HAVE ALP2 RESULTS OF APPROXIMATELY 70 U/L. THE CUSTOMER USED 2 REAGENT LOTS FOR THESE PATIENTS: 730439 (EXPIRATION 29-FEB-2024) AND 747704 (EXPIRATION 31-MAY-2024). FOR BOTH PATIENTS, ALL OTHER RESULTS FROM OTHER PARAMETERS WERE CONSISTENT WITH THEIR PREVIOUS RESULTS. THE CUSTOMER SUSPECTS AN INTERFERENCE AFFECTING THE ALP2 RESULTS FOR BOTH PATIENT SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17671017 ↗
• MalfunctionJun 6, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT'S SAMPLE TESTED WITH ALKALINE PHOSPHATASE (ALP) ASSAY ON A COBAS 6000 C501 MODULE SERIAL NUMBER (B)(6). COMPARED TO A COBAS C503 ANALYZER. ON (B)(6)2023: INITIAL RESULT: 360 UI/L 1ST REPEAT RESULT: 257 UI/L. 2ND REPEAT RESULT: 332 UI/L. 3RD REPEAT RESULT: 294 UI/L. 4TH REPEAT RESULT: 600 UI/L (TESTED ON A COBAS C503). THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17073256 ↗
• MalfunctionNov 23, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FROM OVER FIFTEEN PATIENT SAMPLES TESTED ON THE COBAS 8000 COBAS C 502 MODULE WITH SERIAL NUMBER (B)(4). THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE QC WENT OUT OF RANGE AFTER THE PATIENT SAMPLES WERE RUN WHICH PROMPTED THE REPORTER TO RERUN THE SAMPLES. THE REPORTER STATED THAT THEY BELIEVE THERE WAS A REAGENT PROBE ALARM WITH THE REAGENT PACK THAT WAS IN USE. THE REPORTER DID NOT REALIZE THE RESULTS WERE REPORTED. THE REPORTER WAS ABLE TO PROVIDE THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS: SAMPLE 1 - THE INITIAL RESULT WAS 62 U/L. THE REPEAT RESULT WAS 118 U/L. SAMPLE 2 - THE INITIAL RESULT WAS 196 U/L. THE REPEAT RESULT WAS 374 U/L. SAMPLE 3 - THE INITIAL RESULT WAS 63 U/L. THE REPEAT RESULT WAS 118 U/L. SAMPLE 4 - THE INITIAL RESULT WAS 170 U/L. THE REPEAT RESULT WAS 332 U/L. SAMPLE 5 - THE INITIAL RESULT WAS 92 U/L. THE REPEAT RESULT WAS 168 U/L. SAMPLE 6 - THE INITIAL RESULT WAS 72 U/L. THE REPEAT RESULT WAS 140 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15852708 ↗
• MalfunctionJul 11, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS 6000 C (501) MODULE (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 386 U/L AND REPEATED AS 316 U/L. THE SAMPLE WAS RE-CENTRIFUGED TWICE AND REPEATED FIVE TIMES WITH ALL RESULTS AROUND 200 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14979694 ↗