LIPASE (LPS) LI8050Recalls & reported problems
Randox Laboratories Limited · Class 1
All models of LIPASE (LPS) (4)
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Jun 26, 2020Terminated
Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
Z-2751-2020 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
Other Lipase-Esterase, Enzymatic, Photometric, Lipase devices
- Dimension® Flex® reagent cartridge LIPL 10460277Siemens Healthcare Diagnostics Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall6 reports
- LIPASE (LPS) LI8361Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- VITROS 8297749Ortho-Clinical Diagnostics, Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall0 reports
- LIPASE (LPS) LI7979Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- LIPASE (LPS) LI3837Randox Laboratories Limited · Lipase-Esterase, Enzymatic, Photometric, Lipase1 recall0 reports
- VITROS 1668409Ortho-Clinical Diagnostics, Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE1 recall0 reports
- ADVIA® Chemistry LIP Lipase Reagents 10311896Siemens Healthcare Diagnostics Inc. · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE17 reports
- Lipase colorimetric assay 08057982190Roche Diagnostics GmbH · LIPASE-ESTERASE, ENZYMATIC, PHOTOMETRIC, LIPASE11 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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