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U.S. Department of Health and Human Services

Class 2 Device Recall AEROSET, ARCHITECTURE C8000 & C16000

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  Class 2 Device Recall AEROSET, ARCHITECTURE C8000 & C16000 see related information
Date Initiated by Firm May 04, 2010
Date Posted September 10, 2010
Recall Status1 Terminated 3 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/
Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information Contact
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 2
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 and Original Applicant = ABBOTT LABORATORIES