Alkaline phosphatase acc. to IFCC Gen.2 08056757190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613336120972), received between Apr 15, 2022 and Feb 11, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “High Test Results” (15 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. 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 11, 2026High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE TINA-QUANT C-REACTIVE PROTEIN IV (CRP), TOTAL PROTEIN GEN.2 (TP), AND ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. THIS MEDWATCH WILL COVER ALP. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE CRP RESULTS AND MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE TP RESULTS. THE CUSTOMER WAS PROMPTED TO REPEAT THE PATIENT SAMPLES AS THEY LOOKED LIKE THEY HAD NOT BEEN CENTRIFUGED. SAMPLE 1 HAD AN INITIAL CRP RESULT OF 0.362 MG/DL AND AN INITIAL TP RESULT OF 10.6 G/DL. THE REPEAT CRP RESULT WAS 0.62 MG/DL AND THE REPEAT TP RESULT WAS 7.0 G/DL. SAMPLE 2 HAD AN INITIAL ALP RESULT OF 159 U/L. THE REPEAT RESULT WAS 88 U/L. THE REPEAT RESULTS WERE DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24315651 ↗
• MalfunctionNov 17, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) RESULTS FOR 3 PATIENT SAMPLES ON TWO COBAS C 503 ANALYTICAL UNITS. SAMPLE 1 HAD AN INITIAL ALP RESULT OF 147 U/L FROM ANALYZER B. THE SAMPLE WAS REPEATED ON ANALYZER A AND THE RESULT WAS 272 U/L. THE SAMPLE WAS REPEATED AGAIN ON ANALYZER B AND THE RESULT WAS 103 U/L. SAMPLE 2 WAS TESTED TWICE ON ANALYZER A AND THE RESULTS WERE 123 U/L AND 529 U/L. CLARIFICATION ON WHICH RESULT WAS THE INITIAL AND WHICH WAS THE REPEAT WAS NOT PROVIDED. SAMPLE 3 WAS TESTED TWICE ON ANALYZER B AND THE RESULTS WERE 105 U/L AND 159 U/L. CLARIFICATION ON WHICH RESULT WAS THE INITIAL AND WHICH WAS THE REPEAT WAS NOT PROVIDED. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23574313 ↗
• MalfunctionSep 8, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON TWO COBAS C 503 ANALYTICAL UNIT ANALYZERS. THE SAMPLE INITIALLY RESULTED IN AN ALP RESULT OF 453 U/L. THE SAMPLE WAS TESTED ON A SECOND COBAS C 503 ANALYZER AND THE RESULT WAS 192 U/L. SMALL CELL PARTICLES WERE OBSERVED IN THE PLASMA TUBE USED FOR TESTING. THE SAMPLE WAS ALIQUOTED INTO A SAMPLE CUP, CENTRIFUGED, AND REPEATED, RESULTING IN A VALUE OF 112 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994816 ↗
• MalfunctionAug 28, 2025High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 211 U/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 101 U/L AND 97 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914431 ↗
• MalfunctionJul 22, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR MULTIPLE PATIENT SAMPLES FROM THE COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS AN INITIAL RESULT OF 496 U/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 221 U/L, 74.5 U/L, AND 102 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22563821 ↗
• MalfunctionMay 27, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) ON TWO COBAS C 503 ANALYTICAL UNITS. THE INITIAL RESULT FROM C503 ANALYZER A WAS 116 U/L. THE REPEAT RESULT FROM C503 ANALYZER A WAS 92.1 U/L. THE INITIAL RESULT FROM C503 ANALYZER B WAS 215 U/L. THE REPEAT RESULT FROM C503 ANALYZER B WAS 75.5 U/L. THE SAMPLE WAS REPEATED ON BOTH ANALYZERS AFTER RE-CENTRIFUGATION, AND THE RESULTS WERE 68.8 U/L AND 68.5 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087052 ↗
• MalfunctionFeb 21, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP) AND LACTATE DEHYDROGENASE (LDH) RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL ALP RESULT WAS 213 U/L. THE REPEATED RESULTS WERE 148 U/L, 64.8 U/L, 64.6 U/L, AND 170 U/L. THE INITIAL LDH RESULT WAS 419 U/L AND THE REPEATED RESULTS WERE 277 U/L AND 259 U/L. THE LEUKOCYTE VALUES IN THIS SAMPLE WERE IN THE NORMAL RANGE. THIS MEDWATCH WILL APPLY TO THE ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE LACTATE DEHYDROGENASE ASSAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21433605 ↗
• MalfunctionJan 6, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE (ALP) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 188 U/L AND THE REPEAT RESULTS WERE 86.9 U/L AND 87 U/L. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21084192 ↗
• MalfunctionNov 27, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE HEPARIN PLASMA SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 362 U/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 158 U/L. THE SAMPLE WAS DECANTED INTO A CUP AND REPEATED, RESULTING IN AN ALP VALUE OF APPROXIMATELY 160 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20797754 ↗
• MalfunctionSep 9, 2024High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 ON A COBAS C 503 ANALYTICAL UNIT. THE FIRST SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 1157 U/L. THE SAMPLE WAS REPEATED FIVE TIMES, RESULTING IN VALUES OF 486 U/L WITH A DATA FLAG, 819 U/L, 410 U/L, 409 U/L, AND 442 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 234 U/L. THE REPEAT VALUE OF 234 U/L WAS BELIEVED TO BE CORRECT. THE SECOND SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 345 U/L. THE SAMPLE WAS REPEATED THREE TIMES, RESULTING IN VALUES OF 522 U/L, 391 U/L, AND 367 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 357 U/L. THE REPEAT VALUE OF 357 U/L WAS BELIEVED TO BE CORRECT. THE THIRD SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 729 U/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 445 U/L AND 439 U/L. THE SAMPLE WAS DILUTED 1:5 AND REPEATED, RESULTING IN AN ALP VALUE OF 437 U/L. THE REPEAT VALUE OF 437 U/L WAS BELIEVED TO BE CORRECT. THE FOURTH SAMPLE INITIALLY RESULTED IN AN ALP VALUE OF 206 U/L ON (B)(6) 2024. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 113

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171306 ↗
• MalfunctionApr 26, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 RESULTS FOR 1 PATIENT PLASMA SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL ALP2 RESULT WAS 387 U/L. THE REPEAT RESULT WAS 167 U/L. THE SAMPLE RECENTRIFUGED AND WAS REPEATED AGAIN AND THE RESULT WAS 154 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192772 ↗
• MalfunctionApr 3, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) ON A COBAS C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 217 U/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 165 U/L AND 97.4 U/L. ON (B)(6) 2024 PATIENT 2 INITIAL RESULT WAS 507 U/L. THE SAMPLE WAS REPEATED TWICE WITH RESULTS OF 268 U/L AND 134 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037322 ↗
• MalfunctionApr 2, 2024High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALKALINE PHOSPHATASE (ALP2) RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. PATIENT 1 INITIAL RESULT WAS 419 UI/L AND THE REPEAT RESULTS WERE 708 UI/L AND 524 UI/L. ON (B)(6) 2024, PATIENT 2 INITIAL RESULT WAS 372 UI/L AND THE REPEAT RESULTS WERE 222 UI/L AND 198 UI/L AFTER RECENTRIFUGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019393 ↗
• MalfunctionJan 30, 2024Non 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 RESULT WAS 258 U/L. THE REPEAT RESULT WAS 148 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18608141 ↗
• MalfunctionDec 20, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE AST RESULTS FOR ONE SAMPLE FROM THE COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.60 U/L WITH A DATA FLAG. THE FIRST REPEAT RESULT WAS 24.9 U/L WITH A DATA FLAG. THE SECOND REPEAT RESULT WAS 25.8 U/L. ON (B)(6) 2023, THE REPEAT RESULT WAS 50.4 U/L. IT WAS UNCLEAR IF THE RESULTS WERE GENERATED FROM THE SAME PATIENT SAMPLE. CLARIFICATION WAS REQUESTED BUT WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18363487 ↗
• MalfunctionDec 6, 2023Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER QUESTIONED THE RESULTS FOR MULTIPLE PATIENT SAMPLES TESTED FOR ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) ON A COBAS C 503 ANALYTICAL UNIT. OF THE DATA PROVIDED FOR 6 PATIENT SAMPLES, THE RESULTS FOR 1 PATIENT WERE DISCREPANT. THE INITIAL RESULT WAS 99.4 U/L. THE REPEAT RESULT WAS 119 U/L. THE SAMPLE WAS REPEATED TWICE ON A DIFFERENT ANALYZER AND THE RESULTS WERE 77.5 U/L AND 77.2 U/L. THE INITIAL RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER RUNS ALL ALP2 TESTS IN DUPLICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18274031 ↗
• MalfunctionNov 16, 2023High Test Results; High Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ALKALINE PHOSPHATASE ACC. TO IFCC GEN.2 (ALP2) A COBAS C 303 ANALYTICAL UNIT. THE INITIAL RESULT FROM LINE 1 OF THE ANALYZER WAS 348 U/L WITH AN INVALIDATING DATA FLAG. THE SAMPLE WAS AUTOREPEATED BY THE INSTRUMENT WITH A RESULT OF 539 U/L. THE SAMPLE WAS REPEATED ON LINE 2 OF THE ANALYZER WITH A RESULT OF 252 U/L. THE SAMPLE WAS REPEATED ON LINE 2 WITH A RESULT OF 236 U/L. THE CUSTOMER PERFORMED REPEATABILITY TESTING WITH THE PATIENT SAMPLE ON LINE 1 OF THE ANALYZER WITH RESULTS BETWEEN 114 U/L AND 142 U/L. THE CUSTOMER PERFORMED REPEATABILITY TESTING WITH THE PATIENT SAMPLE ON LINE 2 OF THE ANALYZER WITH A MEAN RESULT OF 115.38 U/L. FOLLOWING REPEATABILITY TESTING, A RESULT OF 120 IU/L WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18148730 ↗
• MalfunctionNov 6, 2023High Test Results; Low Test Results; High Test Results; Low Test 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 379 U/L WITH FLAG. THE REPEAT RESULT WAS 158 U/L. THE LOWER RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074824 ↗
• MalfunctionNov 1, 2023High Test Results; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 2 PATIENTS' SAMPLES TESTED WITH ALKALINE PHOSPHATASE GEN.2 (ALP2) ASSAY ON A COBAS PRO C503 ANALYZER. SAMPLE 1 (PATIENT 1): ON (B)(6)2023: INITIAL RESULT: 283 U/L. 1ST REPEAT RESULT: 467 U/L. ON (B)(6)2023 THE SAME TEST TUBE WAS RE-TESTED: 2ND REPEAT RESULT: 196 U/L. 3RD REPEAT RESULT: 192 U/L. SAMPLE 1 WAS A SERUM SAMPLE. SAMPLE 2 (PATIENT 2): ON (B)(6)2023: INITIAL RESULT: 661 UI/L. RERUN RESULT: 170 UI/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047103 ↗
• MalfunctionOct 20, 2022High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ALP2 ALKALINE PHOSPHATASE RESULTS FOR ONE PATIENT SAMPLE TESTED ON TWO COBAS 6000 C501 MODULES. IT IS UNKNOWN IF THE INITIAL RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS INITIALLY RUN ON A COBAS ANALYZER. AS THE RESULTS SHOWED A PATHOLOGIC LEVEL, THE PATIENT SAMPLE WAS RERUN ON THE TWO COBAS 6000 C501 MODULES (MODULE 1 AND MODULE 2). THE INITIAL RESULT FROM THE COBAS ANALYZER WAS 195 UI/L WITH A DATA FLAG THAT INVALIDATED THE RESULT. THE FIRST REPEAT RESULT FROM THE COBAS ANALYZER BY AUTOMATIC RERUN WAS 238 UI/L. THE SECOND REPEAT RESULT FROM MODULE 1 WAS 132.2 UI/L. THE THIRD REPEAT RESULT FROM MODULE 2 WAS 138 UI/L. THE FOURTH REPEAT RESULT FROM MODULE 2 WAS 288 UI/L. IT IS LIKELY THAT THE LOW RESULTS (132.2 & 138 IU/L) WERE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15644379 ↗
• MalfunctionApr 15, 2022High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ALP2 ALKALINE PHOSPHATASE RESULTS FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 240 U/L WITH A DATA FLAG. THE REPEAT RESULTS WERE 109 U/L, 49.1 U/L, AND 52.6 U/L. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER USED COBAS PURE C 303 ANALYTICAL UNIT SERIAL NUMBER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14117782 ↗