Glucose HK 4657527190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04015630922338), received between Apr 11, 2024 and Apr 27, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Non Reproducible Results” (5 reports).

3 other recalls cover devices cleared under the same FDA submission (K071211); 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• 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 6, 2025Non Reproducible Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF A QUESTIONABLE GLUCOSE HK RESULT FROM THE COBAS C 111 ANALYZER. THE INITIAL RESULT WAS 184 MG/DL. THE REPEAT RESULT WAS 93 MG/DL. THIS RESULT WAS BELIEVED TO BE CORRECT. THE USER REPEATED THE SAMPLE 5 TIMES AND THE RESULTS WERE ALL 106-107 MG/DL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322452 ↗
• MalfunctionAug 22, 2024High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE GLUC3 GLUCOSE HK GEN 3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. THE CUSTOMER ALIQUOTED SERUM INTO AN EPPENDORF TUBE ON THE TOP OF THE PRIMARY SAMPLE TUBE AND THE INITIAL GLUCOSE RESULT WAS 666.8 MG/DL. ANOTHER SERUM SAMPLE COLLECTED AT THE SAME TIME WITH ALIQUOTED SERUM IN AN EPPENDORF TUBE ON TOP OF THE PRIMARY TUBE WAS TESTED AND THE RESULT WAS 167.3 MG/DL. A HEPARIN PLASMA SAMPLE COLLECTED AT THE SAME TIME AS THE INITIAL SERUM SAMPLE WAS TESTED AND THE GLUCOSE RESULT WAS 165.9 MG/DL. THE INITIAL PRIMARY SERUM SAMPLE WAS REPEATED AGAIN WITHOUT AN EPPENDORF TUBE AND THE RESULT WAS 168.8 MG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033458 ↗
• MalfunctionJun 7, 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 GLUC3 GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 111 ANALYZER. THE INITIAL GLUCOSE RESULT OF 536.54 MG/DL. THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 273.71 MG/DL AND 272.79 MG/DL. THE REPEAT RESULTS WERE DEEMED CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486657 ↗
• MalfunctionApr 11, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE CUSTOMER STATED THAT FOR TWO WEEKS, THEY HAVE BEEN HAVING ISSUES WITH QUESTIONABLE PATIENT RESULTS FOR GLUCOSE HK ON A COBAS C 111 ANALYZER. THE CUSTOMER PROVIDED TWO EXAMPLES OF PATIENT SAMPLES WITH DISCREPANT GLUCOSE RESULTS. THE FIRST SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 0.3 MMOL/L AND IT REPEATED AS 0.4 MMOL/L. A NEW REAGENT BOTTLE OF THE SAME LOT WAS THEN USED TO REPEAT THE SAMPLE ON (B)(6) 2024 AND IT RECOVERED WITH A GLUCOSE VALUE OF 4.9 MMOL/L. THE SECOND SAMPLE INITIALLY RESULTED IN A GLUCOSE VALUE OF 0.6 MMOL/L. A NEW REAGENT BOTTLE OF THE SAME LOT WAS THEN USED TO REPEAT THE SAMPLE ON (B)(6) 2024 AND IT RECOVERED WITH A GLUCOSE VALUE OF 10.0 MMOL/L.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19087056 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071211. One submission often covers many models, so check the product and lot details in each record.

• Z-0387-2017 · Sep 27, 2016 · Terminated
  Roche COBAS INTEGRA c111 Analyzer, Chemistry (Photometric, Discrete), for clinical use Product Usage: The Roche COBAS INTEGRA c111 analyzer is an in-vitro diagnostic analyzer capa
• Z-0311-2012 · Oct 18, 2011 · Terminated
  Roche Cobas c 111 Analyzer The Roche Cobas c 111 analyzer is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analy
• Z-1009-2009 · Nov 17, 2008 · Terminated
  Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Roche Diagnostics, Indianapolis, IN. Is an in-vitro diagnostic analyzer capable of performing clinical che