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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67513

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

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Event summary

Timeline bucket
January 01, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Abbott Point Of Care 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

i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnosis, monitoring and treatment of respiratory disturbances and metabolic and respiratory based acid-based disturbances.

Z-1306-2014
Recall number
Z-1306-2014
Initiated
January 01, 2014
Classification
Class II
Status
Terminated
Recalling firm
Abbott Point Of Care Inc.
Quantity
48, 450 US, 1400 OUS (49,850 catridges)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

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

Abbott Point of Care has determined that some individual patient results generated with the i-STAT G3+ cartridge lot N13183 have the potential to exhibit incorrectly elevated PCO2 and depressed pH results.

Code information

List number 03P78-25 :Lot number N13183

Distribution pattern

Worldwide Distribution - USA (nationwide) and Internationally to Canada.