GEM 4000 PAK BG COOX 75 TEST 30 DAY 00027407504Recalls & reported problems
Instrumentation Laboratory Company · GEM Premier 4000 pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2 Cartridge - 75 Test 30DAY · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950554806), received between Jan 29, 2025 and Jan 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2025Leak/Splash; Leak/Splash
THE CUSTOMER REPORTED THAT A GEM PREMIER 4000 PAK CARTRIDGE (CARTRIDGE SERIAL NUMBER:(B)(6), INSTRUMENT SERIAL NUMBER:(B)(6) WAS LEAKING RED FLUID. CUSTOMER USED UNIVERSAL PRECAUTIONS TO CLEAN LEAK. THERE WAS NO OPERATOR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21267053 ↗
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- ABL90 FLEX Analyzer 393-090Radiometer Medical ApS · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH1 recall112 reports
- i-STAT 03P88-25Abbott Point Of Care Inc. · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH105 reports
- GEM Premier 5000 PAK BG/ISE/GL/COOX 300 TEST 00055430010Instrumentation Laboratory Company · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH2 recalls3 deaths3 reports
- GEM Premier 5000 PAK BG/ISE/GL/COOX 450 TEST 00055445010Instrumentation Laboratory Company · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH2 recalls2 reports
- GEM Premier 5000 PAK BG/ISE/GL/COOX 150 TEST 00055415010Instrumentation Laboratory Company · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH2 recalls0 reports
- GEM Premier 5000 PAK BG/ISE/GL/COOX/TBILI 450 TEST 00055445011Instrumentation Laboratory Company · ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH2 recalls0 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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