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

Recall number

Z-1166-2008

Recalling firm

Abbott Laboratories, Inc

Product

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

Status

Terminated

Initiated

2007-09-26

Posted

2008-05-24

Terminated

2012-03-27

Reason

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

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

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.

Lot, serial or model codes

Lot Number: 0505017

510(k) numbers

["K980367"]

PMA numbers

not on file

Product code

CGZ

Firm FEI

1628664

Firm city

Irving

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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