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Terminated

ARCHITECT Processing Module, List number 8C89-01, manufactured by Abbott Laboratories, Irving, Texas

FDA Recall Z-1133-03 · Posted 2003-08-13

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2001-12-10
Date Terminated2003-08-12
Product Quantity787

Reason for Recall

Under specific conditions, the system can allow an incorrect sample ID to be assigned to another sample in a different carrier.

Firm Action

Technical Service Bulletin 114-041 was sent to the Abbott Laboratories Field Service Organization with instructions to correct all ARCHITECT i 2000 systems worldwide.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign countries: Canada, Mexico, Venezuela, Chile, Brazil, Germany, Japan, Singapore, Hong Kong, Taiwan, Thailand, Korea, Australia, New Zealand.

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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