Z-1166-2008

Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064

Name: Z-1166-2008 Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064
Creator: Abbott Laboratories, Inc
Published: 2007-09-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-09-26 / Terminated / root cause: design

FDA source

Abbott Laboratories, Inc began a recall of Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064 on 2007-09-26. The reason FDA records is "Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1166-2008
Status: Terminated
Initiated: 2007-09-26
Posted: 2008-05-24
Terminated: 2012-03-27
Recalling firm: Abbott Medical
Product: Clinical Chemistry ICT Calibrator, List Number: 1E46-02, Abbott Labs, Abbott Park, IL 60064
Product code: CGZ Electrode, Ion-Specific, Chloride
Reason for recall: Quality Control (Out of Range)- ICT Calibrator lot number: 0505017, may contain an interferent. Not all vials within a kit are affected. The investigation determined that the interferent affects Potassium (K+) only. Use of the affected calibrator vials will generate an acceptable, but low calibration slope. When Quality Control (QC) is run to verify the calibration, K+ QC results may be bel
Root cause tag: design
FDA root cause: Component design/selection
Action: An Immediate Action Product Recall dated 9/26/07, was provided to all AEROSET and ARCHITECT cSYSTEM customers that have received Lot Number 0505017. The effectiveness check will be completed through a customer reply form for 100% of US customers. Outside of the U.S. each individual country will determine the methods of effectiveness check. Necessary Actions: If the ICT calibration generates an acceptable slope for (K+), and the calibration is verified by generating QC results within the acceptable range, then the customers may continue to use the lot until a new one is available. If the ICT calibration generates an acceptable slope for (K+) with results below QC range, and (Na+) and (Cl-) are not affected, then they should discontinue use of the Calibrator vials that generate the unacceptable calibration and destroy them following their laboratory procedures. If (Na+) and/or (Cl-) calibration slopes or QC results are not acceptable, additional troubleshooting is required. Questions may be addressed to Abbott Customer Support at 1-877-4ABBOTT.
Quantity in commerce: 1,377 Distributed Worldwide; 419 Domestically
Distribution: Worldwide Distribution --- including USA, Puerto Rico and countries of Mexico, Ecuador, Brazil, Canada, Hong Kong, New Zealand, Venezuela, Chile, , Germany, Thailand, Trinidad/Tobago, Columbia, Argentina, El Salvador, Singapore, Australia, and the Bahama.
Product codes and lots: Lot Number: 0505017

Product code CGZ

K980367Class IIAeroset SystemAbbott Laboratories / cleared 1998-04-01

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)