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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67643

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

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Event summary

Timeline bucket
February 20, 2014
Product types
Device
Classifications
Class II
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 TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease.

Z-1648-2014
Recall number
Z-1648-2014
Initiated
February 20, 2014
Classification
Class II
Status
Terminated
Quantity
583 units Total (357 units domestically & 226 units internationally)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

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Inspect official wording and provenance

Reason for recall

Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results.

Code information

Catalog Number: 139 3396, Lot Number: 1590

Distribution pattern

Worldwide Distribution - USA (nationwide) and the countries of Australia, Brazil, Canada, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, Germany, Italy and Spain.