XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, w

FDA device recall Z-1474-04 · posted 2004-09-18 · Terminated

Recall details

Recalling firm

Abbott Laboratories HPD/ADD/GPRD

Reason for recall

The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.

Action taken

Abbott sent Device Correction letters dated 9/1/04 to all customers receiving the TDx/TDxFLx Benzodiazepines assay, list 9674, informing them of the shift in control values and patient results when used with the XSYSTEMS Dilution Buffer, list 9519-02. The letter gave examples of the effects observed in the benzodiazepines assay performance, and listed the following actions to be taken until Abbott completes their investigation: * During the use of a single lot of buffer, recalibrate the TDx/TDxFLx Benzodiazepines assay every 14 days. * Perform a new calibration run on the TDx/TDxFLx Benzodiazepines assay when a new lot number of XSYSTEMS Dilution Buffer is used. * These actions are in addition to the package insert calibration and quality control requirements. * Follow your laboratory procedures for notification of the health care providers that you serve. Any questions were directed to Abbott''s Customer Service at 1-877-4ABBOTT.

Root cause

Other

Status

Terminated

Product code

JJE

Quantity affected

22,442 cartons

Distribution

Nationwide and internationally to Argentina, Australia, Brazil, Chile, Colombia, Costa Rica, El Salvador, Germany, Guatemala, Honduras, Hong Kong, Mexico, Panama, Peru, Puerto Rico, Singapore, South K

Date initiated

2004-09-01

Date posted

2004-09-18

Date terminated

2004-11-30

Location

Abbott Park, IL