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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69070

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

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Event summary

Timeline bucket
July 18, 2014
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Diagnostica Stago, 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

Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite Analyzers for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

Z-2650-2014
Recall number
Z-2650-2014
Initiated
July 18, 2014
Classification
Class III
Status
Terminated
Recalling firm
Diagnostica Stago, Inc.
Quantity
514 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

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

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Code information

510(k) #K111822, Lot #112366, Part # REF 00311US

Distribution pattern

Distributed USA (nationwide) and the country of Canada.