Class 2 Device Recall AEROSET, ARCHITECTURE C8000 & C16000

• Date Initiated by Firm: May 04, 2010
• Date Posted: September 10, 2010
• Recall Status: Terminated on April 05, 2012
• Recall Number: Z-2398-2010
• Recall Event ID: 55700
• 510(K)Number: K781000
• Product Classification: Phosphomolybdate (colorimetric), inorganic phosphorus - Product Code CEO
• Product: Clinical Chemistry Phosphorus assay
• Code Information: Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).
• Recalling Firm/ Manufacturer: Abbott Laboratories Inc.; 820 Mission St; South Pasadena CA 91030-3142
• For Additional Information Contact: 626-440-0705
• Manufacturer Reason for Recall: Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
• FDA Determined Cause: Other
• Action: Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.
• Quantity in Commerce: 3136
• Distribution: Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CEO