Clinical Chemistry Phosphorus assay

FDA device recall Z-2398-2010 · posted 2010-09-10 · Terminated

Recall details

Recalling firm

Abbott Laboratories Inc.

Reason for recall

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

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.

Root cause

Other

Status

Terminated

Product code

CEO

Quantity affected

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.

Date initiated

2010-05-04

Date posted

2010-09-10

Date terminated

2012-04-05

Location

South Pasadena, CA

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