Non-Esterified Fatty Acids (NEFA) FA115Recalls & reported problems
Randox Laboratories Limited · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records 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 16, 2026.
Recalls naming this device
- May 10, 2021Terminated
Standard packed within NEFA kit has been assigned incorrectly. Calibrating with the incorrect value will cause a positive shift of up to +8% with both quality controls and patient samples
Z-2099-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Sep 23, 2019Terminated
Non-Esterified Fatty Acids (NEFA) FA115 batch 485343 is not meeting the performance claims and should not be used in any further testing.
Z-0367-2020 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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