Glucose HKRecalls & reported problems across all models

We found 3 models of Glucose HK by Roche Diagnostics GmbH in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Jul 26, 2018 and Sep 3, 2026 — classified as 56 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Glucose HK problems

Glucose HK models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Glucose HK 4404483190

  HEXOKINASE, GLUCOSE
  30 reports
• Glucose HK 08057800190

  HEXOKINASE, GLUCOSE
  19 reports
• Glucose HK 4657527190

  HEXOKINASE, GLUCOSE
  7 reports

Recent Glucose HK adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591971 ↗
• MalfunctionSep 3, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50586068 ↗
• MalfunctionAug 31, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50531326 ↗
• MalfunctionAug 14, 2026Insufficient Device Problem Information; Non Reproducible Results; Wrong Label

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50256286 ↗
• MalfunctionApr 27, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH GLUCOSE HK ON A COBAS C 111 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 254.3 MG/DL. A PHYSICIAN REQUESTED A REPEAT OF THE SAMPLE. THE REPEAT RESULT WAS 124.7 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001607 ↗
• MalfunctionMar 17, 2026Incorrect Measurement

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT HIGH RESULTS FOR 1 PATIENT SAMPLE TESTED FOR GLUCOSE HK ON A COBAS C 111 ANALYZER. THE INITIAL RESULT WAS "OVER" 200 MG/DL. THE SPECIFIC RESULT COULD NOT BE PROVIDED. THE REPEAT RESULT WAS 236.19 MG/DL. ON (B)(6) 2026, THE CUSTOMER RECEIVED A COMPLAINT THAT THE PATIENT¿S GLUCOSE RESULT FROM A DIFFERENT LABORATORY WAS "NORMAL." THE SPECIFIC RESULT WAS NOT PROVIDED. THE CUSTOMER REPEATED THE ORIGINAL SAMPLE, AND THE RESULT WAS 79.68 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24615367 ↗
• MalfunctionFeb 19, 2026Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PEDIATRIC PATIENT SAMPLE TESTED WITH GLUCOSE HK ON A COBAS C 111 ANALYZER. THE SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 7.7 MMOL/L. THE SAMPLE WAS REPEATED TWICE, RESULTING IN VALUES OF 5.5 MMOL/L AND 5.45 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388211 ↗
• MalfunctionFeb 17, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE INITIAL REPORTER RECEIVED A QUESTIONABLE GLUCOSE HK GEN.3 ASSAY RESULT FOR ONE PATIENT SAMPLE TESTED ON THE COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.55 MMOL/L (6.6 MMOL/L). THE REPEAT RESULT WAS 4.53 MMOL/L (4.5 MMOL/L). THE INITIAL RESULT WAS INCONSISTENT WITH THE PATIENT'S CONDITION, PROMPTING THE RERUN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24363726 ↗
• MalfunctionFeb 12, 2026Incorrect Measurement

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SERUM SAMPLE ON A COBAS 4000 C311 STAND ALONE SYSTEM AND 7 PATIENT URINE SAMPLES COMPARED TO A COMPETITOR ANALYZER. SAMPLE 1 HAD AN INITIAL SERUM GLUCOSE RESULT OF 129.7 MG/DL. THE REPEAT RESULT WAS 85.6 MG/DL. SAMPLE 2 HAD A URINE GLUCOSE RESULT OF 6.97 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 3 HAD A URINE GLUCOSE RESULT OF 5.66 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 4 HAD A URINE GLUCOSE RESULT OF 2.42 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 5 HAD A URINE GLUCOSE RESULT OF 1.51 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 6 HAD A URINE GLUCOSE RESULT OF 7.98 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL. SAMPLE 7 HAD A URINE GLUCOSE RESULT OF 716 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS >100 MG/DL. SAMPLE 8 HAD A URINE GLUCOSE RESULT OF 2.24 MG/DL. THE URINE GLUCOSE RESULT FROM A H-800 URINE ANALYZER WAS 100 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24324885 ↗
• MalfunctionJan 28, 2026High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS INTEGRA 400 PLUS. THE INITIAL RESULT FROM THE ANALYZER WAS 408.4 MG/DL WITH A DATA FLAG. THE FIRST REPEAT RESULT FROM THE ANALYZER WAS 409.2 MG/DL THE SECOND REPEAT RESULT FROM THE ANALYZER WAS 408.4 MG/DL. THE RESULT FROM A FREESTYLE LITE GLUCOMETER WAS 240 MG/DL. THE TIME INTERVAL BETWEEN THE TESTS WAS NOT PROVIDED. THE REPORTER AND THE DOCTOR QUESTIONED THE RESULT BECAUSE IT DID NOT MATCH THE PREVIOUS PATIENT'S HISTORY IN THE CHART. THE DOCTOR USED THE RESULT FROM THE GLUCOMETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200759 ↗
• MalfunctionJan 16, 2026Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM THE COBAS 8000 COBAS C 502 MODULE. THE INITIAL RESULT WAS 0.26 MMOL/L. THE RESULT WAS 4.79 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095020 ↗
• MalfunctionDec 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 303 ANALYTICAL UNIT. THE PATIENT'S FASTING GLUCOSE RESULT WAS 315 MG/DL. THE PATIENT'S HBA1C RESULT WAS 5.5 %. THE INITIAL GLUCOSE RESULT WAS QUESTIONED, AND THE SAMPLE WAS REPEATED THE NEXT DAY. ON (B)(6) 2025, THE SAMPLE WAS REPEATED, AND THE RESULT WAS 104 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794321 ↗
• MalfunctionSep 3, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 2 PATIENT PLASMA SAMPLES ON A COBAS 6000 C (501) MODULE. THE CUSTOMER WAS PROMPTED TO REPEAT THE INITIAL RESULTS AS THEY HAVE PROTOCOLS TO REPEAT ALL CIRITICAL VALUES. FOR SAMPLE 1, THE INITIAL GLUCOSE RESULT WAS 19 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 89 MG/DL. FOR SAMPLE 2, THE INITIAL GLUCOSE RESULT WAS 39 MG/DL. THE SAMPLE WAS REPEATED ON ANOTHER MODULE AND THE RESULT WAS 119 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22955111 ↗
• MalfunctionMay 27, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FROM THE COBAS 6000 C501 MODULE. THE INITIAL RESULT WAS 14 MG/DL. MEDICATION WAS PROVIDED TO RAISE THE PATIENT¿S GLUCOSE BY AN ESTIMATED 100 POINTS. THE REPEAT RESULT WAS 470 MG/DL. A NEW SAMPLE WAS DRAWN FROM THE PATIENT APPROXIMATELY 30 MINUTES LATER, AND THE RESULT WAS 581 MG/DL. THE RESULTS OF 470 MG/DL AND 581 MG/DL WERE BELIEVED TO BE CORRECT AS THEY WERE CONSISTENT WITH THE PATIENT¿S HEALTH AND HISTORY OF HIGH GLUCOSE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087080 ↗
• MalfunctionMay 9, 2025Non Reproducible Results; Non Reproducible Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED WITH GLUCOSE HK GEN.3 (GLUC3) ASSAY ON A COBAS PURE C303 ANALYTICAL UNIT. INITIAL RESULT: 0.0122 MMOL/L (ACCOMPANIED BY A DATA FLAG). 1ST REPEAT RESULT: -0.00323 MMOL/L (ACCOMPANIED BY A DATA FLAG). THE SAMPLE WAS THEN REPEATED ON A DIFFERENT COBAS PURE INSTRUMENT AT THE SAME FACILITY USING A DIFFERENT LOT NUMBER. THE 2ND AND 3RD REPEAT RESULTS WERE BOTH 0.00673 MMOL/L (ACCOMPANIED BY DATA FLAGS). THE CUSTOMER SUSPECTED AN INTERFERENCE WITH THE APPLIED TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21993038 ↗

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