LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS - LEVEL 3 (LIQ CHEM ASY PREMIUM PL LAE4215Recalls & reported problems
Randox Laboratories Limited · This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Liquid Assayed Chemistry Control Premium Plus is for the control of accuracy. · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- 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, 1 still open.
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
- Aug 3, 2023Class IIOpen, Classified
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet are incorrect, which may lead to misreporting patient results. Target and range values are correct, and risk is mitigated; most clinical labs will use the target and range values in clinical practice.
Z-2609-2023 · Root cause: Under Investigation by firm · 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
- Dried Blood Control 0193Chromsystems Instruments + Chemicals GmbH · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
- SP CONTROL 3 PS2684Randox Laboratories Limited · 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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