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Terminated

ARCHITECT Processing Module, manufactured by Abbott Laboratories, Irving, Texas

FDA Recall Z-0172-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2002-05-08
Date Terminated2003-11-26
Product Quantity1,167 units worldwide

Reason for Recall

If the interlock cable connected to the door lid sensor is disconnected or fails, the lid is detected as closed even though it may be open.

Firm Action

Firm sent technical service bulletins with corrective instructions to consignees with all existing ARCHITECT i 2000 processing modules in February 2003.

Root Cause

Other

Distribution Pattern

States of Virginia, Illinois, New York, Texas, Oklahoma, Pennsylvania, ILlinois, Michigan, California, New Hampshire, Ohio, Florida, Maryland, Nevada, Georgia, Minnesota, Colorado, Arizona, Missouri, Louisiana, Oregon, Wisconsin, Hawaii, Connecticut, New Hampshire, Massachusetts, Washington, South Carolina, Mississippi, Alabama, and Tennessee, and the following foreign countries: Austria, Denmark, Germany, Italy, Poland, South Africa, Sweden, England, Colombia, Australia, Japan, New Zealand, Belgium, Finland, Greece, Netherlands, Portugal, Romania, Turkey, Canada, Mexico, Hong Kong, Korea, Taiwan, Czech Republic, France, Israel, Norway, Saudi Arabia, Spain, United Arab Emirates, Brazil, Venezuela, India, Malaysia, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983212ABBOTT ARCHITECT TESTOSTERONEAbbott Laboratories · 1998-11-18

Official Source

View FDA Recall →

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

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