ARCHITECT 5P02-02Recalls & reported problems
Abbott Ireland · ARCHITECT 25-OH Vitamin D Calibrators · Class 2
All models of ARCHITECT (38)
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
- Apr 24, 2025Open, Classified
transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.
Z-1848-2025 · Root cause: Storage · Recall details · FDA record ↗
Other CALIBRATOR, SECONDARY devices
- ARCHITECT 2K41-27Abbott Laboratories · CALIBRATOR, SECONDARY1 recall374 reports
- ARCHITECT 8K28-02Abbott Laboratories · CALIBRATOR, SECONDARY1 recall115 reports
- VITROS 8231474Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary3 recalls0 reports
- BioPlex 2200 12000651Bio-Rad Laboratories, Inc. · Calibrator, secondary3 recalls0 reports
- ARCHITECT 08K2803Abbott GmbH · Calibrator, secondary1 recall93 reports
- ARCHITECT 7K63-25Abbott Ireland · CALIBRATOR, SECONDARY108 reports
- VITROS 8067324Ortho-Clinical Diagnostics, Inc. · Calibrator, secondary2 recalls0 reports
- VITROS 8568040Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, SECONDARY1 recall18 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.
How reports and recalls are matched · Editorial policy · Report an error on this page