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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71176

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

Open FDA event record

Event summary

Timeline bucket
May 06, 2015
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 Signal Reagent, Product Code 1072693, Unique Device Identifier No. 10758750008360 VITROS Immunodiagnostics Products Signal Reagent (SR) is supplied to users as a sales unit box containing two Signal Reagent Packs. Each Signal Reagent Pack is labeled with a barcode label. The label should include the name of the reagent, a barcode, lot information and expiry dating.

Z-1707-2015
Recall number
Z-1707-2015
Initiated
May 06, 2015
Classification
Class III
Status
Terminated
Quantity
Domestic: 898 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Immunodiagnostic Products Signal Reagent, Lot 3082 as the reagent packs may contain blank labels.

Code information

Lot 3082, expiry date 7/27/2015

Distribution pattern

Nationwide Distribution.