Lactate Dehydrogenase acc. to IFCC ver.2 08057958190Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613336121368), received between Jul 7, 2021 and May 7, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (10 reports).

2 other recalls cover devices cleared under the same FDA submission (K964457); 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 348 U/L. THE REPEAT RESULT WAS 171 U/L. THE SAMPLE WAS REPEATED AGAIN 5 TIMES AND THE RESULTS WERE 172 U/L, 173 U/L, 212 U/L, 177 U/L, AND 175 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25115849 ↗
• MalfunctionFeb 23, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT WAS 372 U/L. THE FIRST REPEAT RESULT WAS 176 U/L. THE SECOND REPEAT RESULT WAS 183 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24421755 ↗
• MalfunctionFeb 11, 2026High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR APPROXIMATELY 10% OF ALL PATIENT SAMPLES TESTED ON A COBAS C 503 ANALYTICAL UNIT. ONE EXAMPLE WAS PROVIDED. THE INITIAL RESULT WAS 540 U/L WITH A DATA FLAG. THE REPEATED RESULTS WERE 366 U/L WITH A DATA FLAG, 0.78 U/L, 235 U/L, 567 U/L, 636 U/L, AND 294 U/L. THE SAMPLE WAS RE-CENTRIFUGED AND RETESTED. THE RESULTS WERE 206 U/L AND 208 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316329 ↗
• MalfunctionJan 26, 2026Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT. EXAMPLE 1 HAD AN INITIAL RESULT OF 241 U/L AND A REPEAT RESULT OF 179 U/L. ON (B)(6) 2026, EXAMPLE 2 HAD AN INITIAL RESULT OF 230 U/L AND REPEAT RESULTS OF 161 U/L AND 182 U/L. EXAMPLE 3 HAD AN INITIAL RESULT OF 216 U/L AND A REPEAT RESULT OF 164 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176654 ↗
• MalfunctionDec 23, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1248 U/L WITH A DATA FLAG. THE SAMPLE WAS AUTOMATICALLY DILUTED, AND THE RESULT WAS 168 U/L. THE INITIAL RESULT AND THE RESULT AFTER THE DILUTION WERE OBTAINED ON MODULE 1. THE SAMPLE WAS REPEATED ON ANOTHER MODULE (MODULE 2), AND THE RESULTS WERE 257 U/L AND 170 U/L. THE RESULT OF 257 U/L WAS QUESTIONED DUE TO IT NOT MATCHING THE PATIENT'S CLINICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23880474 ↗
• MalfunctionDec 19, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 (LDHI2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT FROM LINE 2 WAS 175 U/L. THE CUSTOMER USED THE PATIENT SAMPLE FOR WEEKLY INSTRUMENT COMPARISON TESTING, AND THE RESULT FROM LINE 1 WAS 439 U/L, AND THE RESULT FROM LINE 2 WAS 348 U/L. THE INITIAL RESULT WAS AMENDED TO THE REPEAT RESULT OF 348 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850952 ↗
• MalfunctionDec 8, 2025High Test Results; High Test Results

  THE INITIAL REPORTER QUESTIONED A DISCREPANT HIGH RESULT FOR 1 PATIENT SAMPLE TESTED FOR LACTATE DEHYDROGENASE ACC. IFCC VER.2 (LDHI2) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 653 U/L. THE PHYSICIAN QUESTIONED THIS RESULT. THE SAMPLE WAS REPEATED ON A DIFFERENT C503 ANALYZER WITH A RESULT OF 207 U/L. THE SAMPLE WAS REPEATED ON THE ORIGINAL C503 ANALYZER WITH A RESULT OF 196 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742238 ↗
• MalfunctionNov 19, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS PURE C 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 348 U/L. THE CUSTOMER QUESTIONED THE INITIAL RESULT AS IT WAS INCONSISTENT WITH THE PATIENT'S PREVIOUS RESULT. THE SAMPLE WAS REPEATED THREE TIMES AND THE RESULTS WERE 163 U/L, 169 U/L, AND 167 U/L. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23596614 ↗
• MalfunctionNov 12, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULT FROM THE COBAS C 303 ANALYTICAL UNIT FOR ONE PATIENT. THE INITIAL RESULT ON A C501 INSTRUMENT WAS 192 U/L. THE FOLLOWING WERE REPEAT RESULTS ON THE C303 INSTRUMENT: THE FIRST REPEAT RESULT WAS 932 U/L. THE SECOND REPEAT RESULT WAS 584 U/L. THE THIRD REPEAT RESULT WAS 569 U/L. ON (B)(6) 2025, THE FOURTH REPEAT RESULT WAS 196 U/L. ON (B)(6) 2025, THE FIFTH REPEAT RESULT WAS 201 U/L. ON (B)(6) 2025, THE SIXTH REPEAT RESULT WITH A DILUTION OF 1:2 WAS 103 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531911 ↗
• MalfunctionMar 21, 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 LACTATE DEHYDROGENASE ACC. IFCC VER.2 ON A COBAS C 503 ANALYTICAL UNIT. A LITHIUM HEPARIN TUBE OF THE SAMPLE RESULTED IN AN LDH VALUE OF 270 U/L. A SECOND LITHIUM HEPARIN TUBE COLLECTED FROM THE PATIENT AT THE SAME TIME RESULTED IN AN LDH VALUE OF 608 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662370 ↗
• MalfunctionDec 10, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE ACC. IFCC VER.2 RESULTS FOR ONE PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 501 MG/DL. THE REPEAT RESULT WAS 383 MG/DL. THE INITIAL RESULT WAS QUESTIONED AS IT DID NOT MATCH THE PATIENT'S MEDICAL HISTORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892840 ↗
• MalfunctionSep 26, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SERUM/PLASMA SAMPLE TESTED WITH ALBUMIN GEN.2 (ALB2) ASSAY AND LDHI2 ASSAY ON COBAS C503 ANALYTICAL UNIT. THIS MEDWATCH WILL APPLY TO THE LDHI2 RESULTS. PLEASE REFER TO THE MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE ALB2 ASSAY. ALB2: INITIAL RESULT: 1.18 G/DL. REPEAT RESULT: 3.63 G/DL. LDHI2: INITIAL RESULT: 380 U/L. REPEAT RESULT: 607 U/L. THE PHYSICIAN QUESTIONED THE INITIAL RESULT OF THE ALB2 AS IT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE AND THE SAMPLE WAS THEN REPEATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20310638 ↗
• MalfunctionMar 21, 2024Chemical Problem; Non Reproducible Results; Chemical Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDHI2 ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN LDH VALUE OF 602 U/L. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 350 U/L. THE SAMPLE WAS ALSO REPEATED ON A SECOND ANALYZER, RESULTING IN AN LDH VALUE OF 394 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18949649 ↗
• MalfunctionMar 21, 2022Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LOW LDHI2 LACTATE DEHYDROGENASE VER.2 RESULT FROM COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE INITIAL RESULT WAS 167 U/L. THE REPEAT RESULT AT ANOTHER SITE WAS 409 U/L. ON (B)(6) 2022, THE REPEAT RESULT USING REAGENT LOT NUMBER 618368 WAS 399 U/L. USING A NEW PACK FROM REAGENT LOT 589772, THE RESULT WAS 409 U/L. IT WAS REQUESTED BUT NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838949 ↗
• MalfunctionJul 7, 2021Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 ON A COBAS PRO C 503 ANALYTICAL UNIT (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN A VALUE OF 968 U/L ACCOMPANIED BY A DATA FLAG. THE SAMPLE WAS REPEATED WITH DECREASED SAMPLE VOLUME, RESULTING WITH A VALUE OF 189 U/L. THE SAMPLE WAS THEN REPEATED TWO MORE TIMES WITHOUT DILUTION, RESULTING IN VALUES OF 591 U/L AND 300 U/L. THE SAMPLE WAS TRANSFERRED TO A SAMPLE CUP AND REPEATED ON A SECOND ANALYZER, RESULTING IN A VALUE OF 189 U/L. THE SAMPLE CUP WAS ALSO REPEATED FIVE MORE TIMES ON THE COMPLAINED ANALYZER, RESULTING IN VALUES OF 187 U/L, 190 U/L, 189 U/L, 186 U/L, AND 189 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12131844 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K964457. One submission often covers many models, so check the product and lot details in each record.

• Z-1146-2019 · Dec 17, 2018 · Terminated
  Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for u
• Z-1926-2015 · May 7, 2015 · Terminated
  Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems, cobas c111, Roche/Hitachi MODULAR systems, and cobas c systems for the quantitative determination of lactate c