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Terminated

AEROSET Analyzer, Systems Operation Manual.

FDA Recall Z-0016-05 · Posted 2004-10-09

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-09-24
Date Terminated2005-11-03
Product Quantity835 units

Reason for Recall

Changes to the printer default settings made by users/operators cause printed data to be truncated and misidentified.

Firm Action

The recall was initiated by Device Correction Letter to all AEROSET customers. The Device Correction Letter will be provided to new customers until the new revision of the Operations Manual.

Root Cause

Other

Distribution Pattern

Nationwide and to: Mexico, Columbia, Puerto Rico, Germany, New Zealand, Guatemala, Argentina, Dominican Republic, Hong Kong, Romania, Venezuela, Brazil, Canada, and Australia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K980367AEROSET SYSTEMAbbott Laboratories · 1998-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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