Lactate Dehydrogenase acc to IFCC ver2 3004732122Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04015630916276), received between Mar 13, 2023 and Aug 17, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2026Signal Artifact/Noise

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50286346 ↗
• MalfunctionDec 17, 2025Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH LACTATE DEHYDROGENASE ON A COBAS C 503 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN AN LDH VALUE OF 448 U/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 237 U/L AND 239 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830470 ↗
• 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 LACTATE DEHYDROGENASE (LDH) RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER LDH. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP RESULTS, 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, 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 23657157 ↗
• MalfunctionNov 14, 2025Incorrect Measurement; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results; Incorrect Measurement; Low Test Results; Insufficient Device Problem Information; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 154 U/L. THE DOCTOR QUESTIONED THE RESULT WHICH PROMPTED THE CUSTOMER TO REPEAT THE SAMPLE. THE SAMPLE WAS REPEATED ON ANOTHER C502 ANALYZER AND THE RESULT WAS 310 U/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23556581 ↗
• MalfunctionSep 19, 2024Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE DEHYDROGENASE RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 629 U/L. THE REPEAT RESULTS WERE 884 U/L AND 427 U/L. THE INITIAL RESULT WAS BELIEVED TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261177 ↗
• MalfunctionMar 26, 2024Incorrect, 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 LACTATE DEHYDROGENATE (LDHI GEN.2) RESULTS FROM THE COBAS 6000 C 501 ANALYZER. THE CUSTOMER WAS SWITCHING TO A NEW LOT OF REAGENT AND PERFORMED A PATIENT COMPARISON. THE SAMPLES WERE REPEATED ON ANOTHER COBAS 6000 C 501 USING NEW REAGENT LOT 747707. THE CUSTOMER DID NOT KNOW WHICH RESULT WAS CORRECT. PATIENT 1 INITIAL RESULT WAS 377 U/L AND THE REPEAT RESULT WAS 245 U/L. PATIENT 2 INITIAL RESULT WAS 260 U/L AND THE REPEAT RESULT WAS 153 U/L. PATIENT 3 INITIAL RESULT WAS 390 U/L AND THE REPEAT RESULT WAS 245 U/L. PATIENT 4 INITIAL RESULT WAS 262 U/L AND THE REPEAT RESULT WAS 153 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18979865 ↗
• MalfunctionNov 20, 2023Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LDHI2 LACTATE DEHYDROGENASE ACC. TO IFCC VER.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. THIS MEDWATCH WILL COVER LDHI2. REFER TO MEDWATCH WITH A1 PATIENT IDENTIFIER (B)(6) FOR INFORMATION ON THE ALP2 RESULTS. ON 23-OCT-2023, SAMPLE 1 HAD AN INITIAL LDH RESULT OF 375 U/L. TH SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 592 U/L AND 440 U/L. ON 25-OCT-2023, SAMPLE 2 HAD AN INITIAL LDH RESULT OF 598.0 U/L. THE REPEAT RESULT WAS 254.1 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18170481 ↗
• MalfunctionMar 13, 2023Non 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 INTEGRA 400 PLUS (SERIAL NUMBER (B)(4). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER INITIALLY HAD ISSUES WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES TESTED WITH LDH. THE RESULTS WOULD BE HIGH AND THEN REPEAT LOWER. THE PROBES WERE REPLACED AND PRECISION WAS CHECKED. A WASH STATION WAS ALSO INSPECTED. THE FIELD APPLICATION SPECIALIST UPDATED THE APPLICATION SETTINGS TO USE A DIFFERENT APPLICATION OF THE SAME REAGENT, BUT THE ISSUE STILL PERSISTED LEADING TO THE COMPLAINED SAMPLE RESULTS. THE SAMPLE INITIALLY RESULTED IN AN LDH VALUE OF 733 U/L. DUE TO ONGOING ISSUES OF THE SAME NATURE, THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 211 U/L AND 217 U/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16531778 ↗

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 use on
• 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