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Terminated

Abbott AxSYM System Digoxin III Reagent Pack

FDA Recall Z-1202-2007 · Posted 2007-08-29

Recalling FirmAbbott Diagnostic International, Ltd.
Recall StatusTerminated
Product CodeKXT
Date Initiated2007-03-30
Date Terminated2011-06-10
Product Quantity2,579 kits

Reason for Recall

Customers are receiving error codes (1062, 1063, 1113, & 1118) when running patient samples on the AxSYM Digoxin III assay.

Firm Action

On Abbott letterhead dated March 30, 2007 - The instructions are to provide a copy of the accompanying Product Correction Letter to the laboratory manager/supervisor responsible for AxSYM Digoxin II or AxSYM Digoxin III testing. The laboratory manager/supervisor should complete the information on the letter acknowledging receipt of the product Correction Letter and Fax the Customer Reply Form, prior April 12, 2007 to Fax number 1-800-777-0051.

Root Cause

Other

Distribution Pattern

Worldwide, including USA, Puerto Rico, Canada, Uruguay, Germany, Japan, Hong Kong, South Korea, Australia, and New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K061249AXSYM DIGOXIN IIIAbbott Laboratories · 2006-06-02

Official Source

View FDA Recall →

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

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