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Terminated

The AXSYM System, Clinical Chemistry Analyzer, Manufactured by Abbott Laboratories, Irving, Texas

FDA Recall Z-0274-04 · Posted 2003-12-25

Recalling FirmAbbott Laboratories, Inc
Recall StatusTerminated
Product CodeJJE
Date Initiated2003-10-29
Date Terminated2007-11-13
Product Quantity17,850

Reason for Recall

Potential for a contaminated Reaction Vessel (RV) or previously used RV to remain on the AxSYM System.

Firm Action

All current US AxSYM System consignees will receive the Device Correction letter via direct mailing. A 100% effectiveness check will be performed against AxSYM consignees not responding, via Customer Reply Form. An electronic copy of the Device Correction letter and communication package will be provided to all Abbott Affilities worldwide for communicating with their customers.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K974651ABBOTT AXSYM SYSTEMAbbott Laboratories · 1998-02-12

Official Source

View FDA Recall →

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

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