Lactate Gen.2 3183700190Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04015630918911), received between Jul 24, 2018 and Dec 5, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “High Test 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE LACTATE/LACTATE STAT ASSAY RESULT FOR A PATIENT SAMPLE TESTED ON A COBAS 6000 C (501) MODULE. THE INITIAL RESULT WAS 0.25 MMOL/L. THE REPEAT RESULT WAS 2.54 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728711 ↗
• 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/LACTATE STAT RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 COBAS C 502 MODULE. THIS MEDWATCH WILL COVER LACTATE. 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 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 23657159 ↗
• MalfunctionMar 19, 2025High Test Results; High Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LACTATE/LACTATE STAT RESULTS FROM THE COBAS INTEGRA 400 PLUS COMPARED TO A MYKOV (KOVALENT) SYSTEM. SAMPLE 1 INITIAL RESULT WAS 44.49 MG/DL, AND THE MYKOV RESULT WAS 6.1 MG/DL. SAMPLE 2 INITIAL RESULT WAS 109.47 MG/DL, AND THE MYKOV RESULT WAS 70.9 MG/DL. SAMPLE 3 INITIAL RESULT WAS 41.7 MG/DL, AND THE MYKOV RESULT WAS 23.7 MG/DL. THE RESULTS FROM THE INTEGRA WERE NOT RELEASED OUTSIDE OF THE LAB AS THEY WERE DEEMED TO BE INCORRECT AND DID NOT MATCH THE PATIENT'S CLINICAL STATUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21641469 ↗
• MalfunctionDec 21, 2021High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE LACT2 LACTATE GEN.2 RESULT FOR ONE PATIENT SAMPLE WITH A COBAS 8000 COBAS C 502 MODULE SERIAL NUMBER UNKNOWN. THE REPORTER STATED THAT QC WAS OUT OF RANGE AT THE END OF TESTING, THEY REPLACED THE REAGENT PACK AND QC RESUMED TO NORMAL. ALL SAMPLES BETWEEN THE FAILED QC AND MOST RECENT SUCCESSFUL QC WERE REPEATED. THE INITIAL RESULT WAS 2.62 MG/DL. THE REPEATED RESULT FROM A C503 WAS 1.83 MG/DL. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13053761 ↗
• MalfunctionJul 24, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR LACT2 LACTATE GEN.2 (LACT) ON A COBAS INTEGRA 400 PLUS (I400+). THE SAMPLE INITIALLY RESULTED AS 0.11 MMOL/L AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY TO THE WARD. THE RESULT DID NOT MATCH PREVIOUS RESULTS OF THE PATIENT, SO THE WARD COMPLAINED ABOUT THE RESULT. CONTROLS WERE MEASURED ON THE LACT ASSAY AND THEY WERE FOUND TO BE TOO LOW. THE CUSTOMER CHANGED THE REAGENT CASSETTE AND REPEATED THE SAMPLE. THE REPEAT RESULT OF THE SAMPLE WAS 1.78 MMOL/L. CONTROLS WERE REPEATED ON THE NEW CASSETTE AND THE VALUES WERE WITHIN RANGE, MATCHING PREVIOUS VALUES. NO ADVERSE EVENTS WERE ALLEGED TO HAVE OCCURRED WITH THE PATIENT. THE I400+ ANALYZER SERIAL NUMBER WAS (B)(4). THE INVESTIGATION WAS UNABLE TO FIND A DEFINITIVE ROOT CAUSE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713486 ↗