GEM CVP (Calibration Valuation Product) 1 with CO-OX 00025000115Recalls & reported problems
Instrumentation Laboratory Company · GEM CVP (Calibration Valuation Product) 1 with CO-OX · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08426950440680), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Handling 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.
Most reported problems
Device problems
- Device Handling Problem1
Patient problems
- Needle Stick/Puncture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 10, 2018Device Handling Problem; Device Handling Problem
IT WAS REPORTED THAT A CUSTOMER CUT THEIR FINGER WHILE SNAPPING OPEN A CVP VIAL. THE CUSTOMER REPORTED THAT IT WAS A MINOR CUT. HE REMOVED GLOVES TO WASH HANDS WITH SOAP AND WATER, THEN USED A BANDAGE.
Patient problems: Needle Stick/Puncture
MAUDE report 7415356 ↗
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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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