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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84260

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 28, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diagnostics Operations, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0669-2020
Recall number
Z-0669-2020
Initiated
October 28, 2019
Classification
Class II
Status
Terminated
Quantity
712 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10).

Code information

Anti-HAV IgM APP-file (version 06.05-101)

Distribution pattern

US Nationwide distribution.