GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 00044307510Recalls & reported problems
Instrumentation Laboratory Company · GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 75 test PAK · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08426951070770), received between Mar 12, 2025 and Mar 12, 2025 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE HIGHER THAN EXPECTED WHEN COMPARED TO RESULTS FROM THEIR LABORATORY ANALYZER (ROCHE COBAS). NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21589410 ↗MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE ERRONEOUSLY HIGH. PATIENTS WERE SENT FOR ADDITIONAL TESTING IN THE EMERGENCY DEPARTMENT WITH SAMPLES SENT TO THE LABORATORY (BECKMAN AU CREATININE JAFFE ASSAY), AND THE RESULTS WERE WITHIN NORMAL RANGE. NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21587778 ↗
Other Electrode, Ion Specific, Sodium devices
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- Sodium electrode 10825468001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM26 reports
- Sodium Electrode 21029371001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM25 reports
- GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 00044345010Instrumentation Laboratory Company · Electrode, Ion Specific, Sodium19 reports
- i-STAT 03P81-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM15 reports
- i-STAT 03P82-25Abbott Point Of Care Inc. · ELECTRODE, ION SPECIFIC, SODIUM10 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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