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Recall Observatory FDA recall evidence

Derived label

Device software or design

Elecsys Anti-HAV IgM assay-for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma Catalog number: 07026773190

reason.device_software_design

v1.0.0

Assignment summary

Mode key
device_software_design
Evidence excerpt
software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous
Rule explanation
Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.
Firm
Roche Diagnostics Operations, Inc.

Field note

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