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Terminated

ARCHTECT System RS-232 Manual, product list number 06F71-04, for the ARCHITECT i2000 Processing Module and the ARCHITECT c8000 Processing Module. The product is manufactured and distributed by Abbott Laboratories Diagnostic Division, Irving, TX 75038

FDA Recall Z-0818-04 · Posted 2004-07-20

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2004-03-19
Date Terminated2005-11-03
Product Quantity101

Reason for Recall

When using a LIS the software system will send up a test result of up to 20 characters although the field is set to display only 15 characters per the RS-232 Manual.

Firm Action

Customers were notified by letter on March 23, 2004 to contact their LIS vendor and to reconfigure the ASTM Field 10.1.4 to allow a maximum character length of 20 characters.

Root Cause

Other

Distribution Pattern

Nationwide and to the following foreign countries: Chile, Canada, Germany, Taiwan, Australia, Signapore

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K983212ABBOTT ARCHITECT TESTOSTERONEAbbott Laboratories · 1998-11-18K980367AEROSET 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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