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Terminated

AEROSET System Software version 1.02ER000

FDA Recall Z-0091-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJQP
Date Initiated2003-09-30
Date Terminated2004-04-07
Product Quantity133

Reason for Recall

Audible alarm occurs before aspiration potentially resulting in operator injury or results assigned to wrong patient for STAT samples.

Firm Action

The firm issued a letter on 09/30/2003 notifying customers of the Device Correction and provided instructions to disable the audible alert. Abbott Diagnostics will correct this issue in the next revision of the AEROSET System Software.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign countries: Norway, United Kingdom, Hong Kong, United Arab Emirates, Canada, New Zealand, and China

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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