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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64876

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

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Event summary

Timeline bucket
April 15, 2013
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Abbott Diabetes 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

FreeStyle InsuLinx Blood Glucose Monitoring System: For In Vitro Diagnostic Use only. Use only with FreeStyle InsuLinx test strips. Abbott Diabetes Care, Inc. 1360 South Loop Road Alameda, CA 94502 USA The FreeStyle InsuLinx Blood Glucose Test Strips are for use with the FreeStyle InsuLinx Blood Glucose Meter to quantitatively measure glucose in capillary whole blood samples drawn from the fingertip.

Z-1245-2013
Recall number
Z-1245-2013
Initiated
April 15, 2013
Classification
Class I
Status
Terminated
Quantity
335,273 meters; 209,336 remain at firm.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

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

AT rare, extremely high glucose levels (1024 mg/dL and above), the FreeStyle InsuLinx Blood Glucose Meter may provide an inaccurate reading.

Code information

Part Numbers: 71142-70 71143-70 71145-70 71150-70: All serial and lot numbers.

Distribution pattern

Nationwide Distribution