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Terminated

Abbott Aeroset System list number 9D05-01, manufactured by Abbott Diagnostic Division, Irving, Texas

FDA Recall Z-1142-03 · Posted 2003-08-21

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2000-12-29
Date Terminated2003-08-20
Product Quantity143

Reason for Recall

ICT assays run using a manual dilution will not be calculated correctly by the software.

Firm Action

Product Information letter dated 29 December 2000 was sent to all AEROSET customers.

Root Cause

Other

Distribution Pattern

Nationwide and to the following countries: Brazil, Canada, Australia, New Zealand, Columbia, Venezuela, Argentina, Finland, France, Germany, Greece, Hong Kong, United Kingdom, Japan, Singapore, China, Italy, Ireland, Korea, Thailand, Turkey, Norway, India

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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