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Terminated

AEROSET ICT Module, Reagent module for sodium, potassium, and chloride. List number 9D05-01.

FDA Recall Z-0788-03 · Posted 2003-05-01

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-02-24
Date Terminated2004-10-28
Product Quantity645 units

Reason for Recall

Software failure to detect error in reference solution set-up can cause inaccurate results for Sodium, Potassium, and Chloride.

Firm Action

A Device Correction Letter was sent to all AEROSET System customers on 2/24/2003 informing them of the issue and measure they must take to minimize the risk of occurrence.

Root Cause

Other

Distribution Pattern

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

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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