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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77108

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

Open FDA event record

Event summary

Timeline bucket
April 10, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Roche Diagnostics Corporation

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 PreciControl Varia 3

Z-2173-2017
Recall number
Z-2173-2017
Initiated
April 10, 2017
Classification
Class II
Status
Terminated
Quantity
1603

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

e-barcode and value sheet for PreciControl Varia contains a typographical error for the target values for the Elecsys PTH (parathyroid hormone) and Elecsys PTH STAT immunoassays

Code information

Lot Number: 189285 Expiration Date: 10/31/2017 Part Number: PreciControl Varia: 05618860160

Distribution pattern

Nationwide