ARCHITECT 2P36-01Recalls & reported problems
Abbott GmbH · ARCHITECT HIV Ag/Ab Combo Calibrator · Class 2
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. How this data works · Data updated Oct 13, 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-1845-2025 · Root cause: Storage · FDA record ↗
Other Test, hiv detection devices
- Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection409 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2648Alere Scarborough, Inc. · Test, Hiv Detection238 reports
- Elecsys HIV Duo 08836973190Roche Diagnostics GmbH · Test, HIV detection105 reports
- cobas® HIV-1 09040803190Roche Molecular Systems, Inc. · Test, HIV detection27 reports
- Alere Determine™ HIV–1/2 Ag/Ab Combo 7D2649Alere Scarborough, Inc. · Test, Hiv Detection27 reports
- VITROS 6842781Ortho Clinical Diagnostics · Test, hiv detection16 reports
- RealTime 6L18-90Abbott Molecular Inc. · Test, hiv detection12 reports
- ADVIA Centaur® CHIV 10696880Siemens Healthcare Diagnostics Inc. · Test, Hiv Detection9 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.