System, Test, Human Chorionic Gonadotropin
FDA adverse event reports and recall history for system, test, human chorionic gonadotropin (product code DHA), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 3,553
- Deaths
- 1
- Injuries
- 94
- Malfunctions
- 3,403
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
- 2023-01-17Open, ClassifiedMaterial/Component Contamination
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reaction vessels may contain a potential contaminant that could affect their optical performance.
- 2016-01-07TerminatedLabeling design
Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care hCG method Catalog Number: CBHCG SMN:10445060
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- 2016-01-07TerminatedLabeling design
Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of the Stratus CS Acute Care rM ~ h CG method Catalog Number: CBHCG-C SMN:10445061
Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems
- 2011-03-11TerminatedPMA
Free beta-hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 2011-03-11TerminatedPMA
Visual hCG ELISA kit BioCheck, Foster City, CA 9440. Quantitative determination of AFP concentration in human serum.
Product labels indicate that the products are for IVD use and they do not have an approved 510(k).
- 2006-05-19TerminatedOther
Stratus CS STAT Fluorometric Analyzer BHCG TestPak (CBHCG) in vitro diagnostic.
Foil sealing of theTestPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
- 2006-05-19TerminatedOther
Stratus CS STAT Fluorometric Analyzer BHCG DilPak (CBHCG-D) in vitro diagnostic.
Foil sealing of the DilPak may occlude the pipet tip resulting in insufficient aspiration of fluids. Erroneous test results may be generated without an associated error code. Test results may be falsely elevated or depressed, and the magnitude of the inaccuracy may vary based on the degree of occlusion.
- 2005-10-06TerminatedOther
Nichols Advantage Invasive Trophoblast Antigen (ITA)Assay Cartridges (Catalog #62-7052)
Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
- 2005-10-06TerminatedOther
Hyperglycosylated Human Chorionic Gonadotropin (H-hCG) Assay Cartridges (Catalog#62-7039)
Data from internal testing indicates that the Nichols Advantage Invasive Trophoblast Antigen Assay Cartridges (ITA)(Lot No 62-500261) and Hyperglycosylated Human Chorionic Gonadotropin Assay Cartridges (H-hCG)(Lot No 62-500262) does not maintain its stability over the 12 month expiration dating of the product, and that stability is assured only through 6 months.
- 2004-11-30TerminatedOther
Immulite 2500 Automated Immunoassay Analyzer, Human chorionic gonadotrpin (HCG) test system.
Erroneous handling of samples will cause problems after the system is placed in 'Sample-pause'.
Monitor system, test, human chorionic gonadotropin automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.