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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62595

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

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Event summary

Timeline bucket
July 02, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Greiner Bio-One North America, 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

3mL 9NC Coagulation Sodium Citrate 3.2%, Item #454334, Greiner Bio-One North America Inc., 4238 Capital Drive, Monroe, NC 28110. Intended Use: Venous blood collection tubes.

Z-2154-2012
Recall number
Z-2154-2012
Initiated
July 02, 2012
Classification
Class II
Status
Terminated
Quantity
838.9 cases (1,006,700 pieces)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Part of the lot received a lower concentration of citrate solution which may cause falsely lower values for common coagulation tests.

Code information

Lot #B041206

Distribution pattern

Nationwide Distribution