GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 00044330010Recalls & reported problems
Instrumentation Laboratory Company · GEM Premier ChemSTAT PAK Na+, K+, Ca++, Cl-, Glu, Crea, BUN, tCO2, Hct, Lac, pH, pCO2 300 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 08426951070794), received between Mar 12, 2025 and Nov 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Ingredient or Reagent Problem” (1 report).
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
- Device Ingredient or Reagent Problem1
- Incorrect Measurement1
- No Apparent Adverse Event1
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.
MalfunctionNov 7, 2025Incorrect Measurement; Device Ingredient or Reagent Problem; Incorrect Measurement; Device Ingredient or Reagent Problem
POOR PERFORMANCE FOR CREATININE ON CHEMSTAT ON CHEMSTAT SYSTEM WAS OBSERVED DURING A RECENT EQA DISTRIBUTION (B)(4). IN ADDITION, PATIENT RESULT DISCREPANCIES WERE OBSERVED ON CARTRIDGE DETAILS. THE SAME CARTRIDGE WAS EXHIBITING MULTIPLE "SOLUTION DETECT ERROR DURING SAMPLE" AND REQUIRED REPLACEMENT ON 10/08/2025 DUE TO A "REFERENCE VOLTAGE ERROR". CUSTOMER REPORTED THAT THE NEW CARTRIDGE (BATCH 20908C, SERIAL NUMBER (B)(6) IS PERFORMING MORE IN LINE WITH THEIR CREATININE EXPECTATIONS. NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23500580 ↗MalfunctionMar 12, 2025No Apparent Adverse Event; No Apparent Adverse Event
A CUSTOMER REPORTED THAT CREATININE RESULTS FROM A GEM PREMIER CHEMSTAT PAK (CARTRIDGE) WERE DRIFTING HIGHER OUTSIDE THE REFERENCE RANGE FOR CREATININE: 0.80-1.40 MG/DL. SUBSEQUENTLY, THE CUSTOMER CONDUCTED A CORRELATION STUDY, AND RESULTS FROM THE GEM PREMIER CHEMSTAT PAK WERE 0.3-0.5 MG/DL HIGHER THAN THOSE OBTAINED USING THEIR CHEMISTRY METHOD (JAFFE CREATININE ASSAY). NO PATIENT IMPACT WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21589053 ↗
Other Electrode, Ion Specific, Sodium devices
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- Sodium electrode 10825468001Roche Diagnostics GmbH · ELECTRODE, ION SPECIFIC, SODIUM99 reports
- 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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