ICT Calibrator 의 리콜

Recall

46389

Class 3

Z-1166-2008

2008-05-24

Terminated

United States

2012-03-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=67360

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.

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.