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Terminated

AEROSET Software versions 1.00ER005, catalog number 2-89996-01 and 1.00ER005.2, catalog number 2-89996-02

FDA Recall Z-0725-03 · Posted 2003-04-16

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

Reason for Recall

Under certain operating conditions, smart wash feature disables with multiple samples.

Firm Action

A device correction letter was sent 02/24/2003 to all AEROSET customers with a US Customer Reply Form. A Technical Service Bulletin will be released to include the Device Correction letter and instructions for Field Service Personnel. A Quality Directive will be issued to provide instructions to Customer Service.

Root Cause

Other

Distribution Pattern

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

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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