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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74002

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

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Event summary

Timeline bucket
April 26, 2016
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

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

Z-1923-2016
Recall number
Z-1923-2016
Initiated
April 26, 2016
Classification
Class II
Status
Terminated
Quantity
250,800 pieces (209 cases)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Inspect official wording and provenance

Reason for recall

The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Code information

Lot A151137L

Distribution pattern

Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico