Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbo

FDA device recall Z-2222-2009 · posted 2009-09-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories

Reason for recall

The AxSYM Cancer Assay Disk (LN 3D50-05 version 5.0) contains an AxSYM AFP assay file where the Low Concentration flag for the AFP 1:101 automated dilution protocol the instrument to report results between 0 ng/mL and 0.4 ng/mL (40.4 ng/mL accounting for the 1:101 dilution). The sensitivity of the assay is 0.4 ng/mL.

Action taken

Abbott sent "Product Correction Immediate Action Required" letters dated February 2, 2009 to all AxSYM AFP customers. Customers were requested to install the updated version of the AxSYM AFP assay using version 6.0 of the AxSYM Cancer Assay Disk provided with the letter and to retain a copy of this communication for their records. Any questions regarding the letter were directed to Customer Service at 1-877-4ABBOTT.

Root cause

Device Design

Status

Terminated

Product code

LOJ

Quantity affected

8,205 disks

Distribution

Worldwide Distribution -- United States (including Puerto Rico), Australia, Bahamas, Barbados, Bermuda, Brazil, Canada, Cayman Islands, Chile, Columbia, Costa Rica, Curacao (Neth Ant), Dominican Repub

Date initiated

2009-02-20

Date posted

2009-09-18

Date terminated

2010-08-23

Location

Abbott Park, IL