Test, Hiv Detection
FDA adverse event reports and recall history for test, hiv detection (product code MZF), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,153
- Deaths
- 4
- Injuries
- 123
- Malfunctions
- 2,938
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-05-27Open, ClassifiedStorage
ABBOTT DIAGNOSTICS ARCHITECT HIV COMBO 1X4ML CALIBRATOR.
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.
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