Recalling Firm / Manufacturer

Abbott Laboratories, Inc

Product

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

Code Information

Lot Number: 0505017

Reason of 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

Date Recall Initiated

December 14, 2007

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.

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

Contact

Abbott Diagnostics Division
Riyadh
8001241238

Source of Information

U.S.FDA

SFDA Comments

SFDA urges all hospitals that have devices subjected to recall, to contact the company.