FDA Device

Clinical Chemistry Phosphorus assay

Hazard

Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.

What You Should Do

Remedy

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.

Products

Clinical Chemistry Phosphorus assay
Brand
Abbott Laboratories Inc.
UPC
Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).

Units Affected

3136