Insulin HYE-5361Recalls & reported problems
DRG Instruments Gesellschaft mit beschränkter Haftung · The DRG:HYBRId-XL Insulin is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Insulin in serum and plasma (EDTA and Heparin). · Class 1
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- Oct 7, 2024Open, Classified
The user of the assay may either face a failure message during re-calibration of the Hybrid.XL instrument using the re-calibration R1 and R2 of the device or find controls out of specification (failed Control High) which causes a delay in results.
Z-0921-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Radioimmunoassay, Immunoreactive Insulin devices
- Elecsys Insulin 07027559190Roche Diagnostics GmbH · RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN18 reports
- Elecsys Insulin 12017547122Roche Diagnostics GmbH · RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN12 reports
- Alinity 04T7520Abbott GmbH · RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN11 reports
- ARCHITECT 08K4128Abbott GmbH · RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN8 reports
- ARCHITECT 8K41-27Abbott Laboratories · RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN2 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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