Clinical Chemistry Phosphorus assay
This recall has been terminated (originally issued September 10, 2010).
- Company
- Abbott Laboratories Inc.
- Recall Initiated
- May 4, 2010
- Posted
- September 10, 2010
- Terminated
- April 5, 2012
- Recall Number
- Z-2398-2010
- Quantity
- 3136
- Firm Location
- South Pasadena, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
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.
Lot / Code Info
Lot number: 81040HW00; expires July 15, 2010, 85009HW00; expires December 15th, 2010. (All Lots of Clincal Phosphorous LN 7D71-21).
Root Cause
Other
Action Taken
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.