ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or p

FDA device recall Z-2059-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Abbott Laboratories Inc.

Reason for recall

An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package insert. In addition, the 14 day calibration interval is also not being met. Further investigation is required to determine the root cause of this issue. Until the cause has been determined and a corrective action defined, specific instructions ar

Action taken

On February 15, 2008 A Product Correction letter with instrument specific attachments was provided to all Clinical Chemistry Phenytoin customers that have received the affected lots. A customer reply form was included in all US customers letter. The letter instructed customers to follow the attached instrument specific actions as described in the attachments (Attachment A: ARCHITECT cSYSTEM, Attachment B: AEROSET). Customers were also instructed to forward a copy of the Product Correction letter to any other laboratories to which they may have forwarded the affected product. If you have questions, U.S. customers should call Customer Support at 1-800-4ABBOTT and customers outside of the U.S. should contact your local customer support.

Root cause

Other

Status

Terminated

Product code

DIP

Quantity affected

3266 Worldwide, 2009 Domestically

Distribution

Nationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore

Date initiated

2008-02-15

Date posted

2008-09-16

Date terminated

2012-03-23

Location

South Pasadena, CA

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