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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 60514

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

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Event summary

Timeline bucket
June 06, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sendx Medical 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

ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gases, electrolytes, glucose and oximetry (ABL80 FLEX CO-OX only) in whole blood. The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) analyzer systems are intended for use by trained technologists, nurses, physicians and therapists. They are intended for use in a laboratory environment, near patient or point-of-care setting.

Z-2304-2012
Recall number
Z-2304-2012
Initiated
June 06, 2012
Classification
Class II
Status
Terminated
Recalling firm
Sendx Medical Inc
Quantity
ABL80 FLEX is 1680, ABL80 CO-OX is 1759

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm recalled because the glucose measurements from a patient sample that the customer felt was too low and did not reflect the patient's clinical condition.

Code information

Model Numbers: 393-839 (with 933-082 software) and 393-841 (with 933-132 software) All Serial Numbers

Distribution pattern

Worldwide Distribution - US Nationwide including the state of OH.