Z-1474-04

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

Name: Z-1474-04 XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in...
Creator: Abbott Laboratories HPD/ADD/GPRD
Published: 2004-09-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-09-01 / Terminated

FDA source

Abbott Laboratories HPD/ADD/GPRD began a recall of XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950... on 2004-09-01. The reason FDA records is "The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1474-04
Status: Terminated
Initiated: 2004-09-01
Posted: 2004-09-18
Terminated: 2004-11-30
Recalling firm: Abbott Medical
Product: XSYSTEMS Dilution Buffer, list number 9519-02; for In Vitro diagnostic use, Bovine gamma globulin in Phosphate buffer, with Sodium Azide as a preservative; 950 mL bottle, 4 bottles per carton; Abbott Laboratories, Abbott Park, IL 60064 USA
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: The XSYSTEMS Dilution Buffer when used with TDx/TDxFLx Benzodiazepines assay can cause shifts in control values and patient results.
FDA root cause: Other
Action: 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.
Quantity in commerce: 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 Korea, Taiwan, Thailand, the United Kingdom, Uruguay and Venezuela
Product codes and lots: list number 9519-02, all lots

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)