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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93632

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

Open FDA event record

Event summary

Timeline bucket
November 27, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ortho-Clinical Diagnostics, 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

VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic Products Anti-HBs Calibrators, Catalog No. 6801926

Z-0772-2024
Recall number
Z-0772-2024
Initiated
November 27, 2023
Classification
Class II
Status
Ongoing
Quantity
6,920 US; 57 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Affected lots may experience increased calibration failures or an increase in falsely elevated results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Affected lots may experience increased calibration failures or an increase in falsely elevated results.

Code information

UDI-DI 10758750001682 Lots 8931 8940 8955 8960 8970 8980 8990

Distribution pattern

Domestic distribution nationwide. OUS distribution to Bermuda, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Mexico, Singapore, UK, France, Germany, Italy, Spain, Portugal, Russia, Denmark, Norway, Sweden, France, Belgium, and The Netherlands.