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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85298

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

Open FDA event record

Event summary

Timeline bucket
March 10, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Ortho Clinical Diagnostics

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 TT4 Reagent Pack, Product Code 8744468

Z-1834-2020
Recall number
Z-1834-2020
Initiated
March 10, 2020
Classification
Class III
Status
Terminated
Quantity
3181

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The specified reagent packs exhibit an increase in the frequency of unsuccessful calibrations.

Code information

UDI: 10758750005147; Lot Number: 2340

Distribution pattern

US Nationwide. Australia, Bermuda, Belgium, Brazil, Canada, Chile, China, Columbia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, UK.