Recall StatusTerminated
Date Initiated2010-05-04
Date Terminated2012-04-05
Product Quantity3136
Reason for Recall
Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.
Firm 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.
Distribution Pattern
Worldwide Distribution: US, including Puerto Rico, and countries of Germany, New Zealand, Trinidad/Tobago, Cayman Island, Hong Kong, Chile, Curacao, Jamaica, Australia, and Bahamas.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.