BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) BG5002Recalls & reported problems
Randox Laboratories Limited · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Feb 13, 2019Class IITerminated
An error in the assignment of the control range pH in Blood Gas Control
Z-1057-2019 · Root cause: Process control · Recall details · FDA record ↗
Other Multi-Analyte Controls, All Kinds (Assayed) devices
- BioPlex 2200 6633200Bio-Rad Laboratories, Inc. · Multi-analyte controls, all kinds (assayed)1 recall0 reports
- Dried Blood Control 0192Chromsystems Instruments + Chemicals GmbH · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-101Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- MAS Omni-CARDIO Liquid Assayed Integrated Cardiac Control OCRD-202Microgenics Corporation · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- SP CONTROL 1 PS2682Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- Cholestech LDX™ 88773Alere San Diego, Inc. · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL LAE4215Randox Laboratories Limited · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- Dried Blood Control 0193Chromsystems Instruments + Chemicals GmbH · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- 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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