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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Clinical Chemistry Phenytoin Assay

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 Class 2 Device Recall Abbott Clinical Chemistry Phenytoin Assaysee related information
Date Initiated by FirmFebruary 15, 2008
Date PostedSeptember 16, 2008
Recall Status1 Terminated 3 on March 23, 2012
Recall NumberZ-2059-2008
Recall Event ID 48173
510(K)NumberK993026 
Product Classification Diphenylhydantoin enzyme immunoassay, - Product Code DIP
ProductABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
Code Information Lot Numbers:42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
FEI Number 2018433
Recalling Firm/
Manufacturer		 Abbott Laboratories Inc.
820 Mission St
South Pasadena CA 91030-3142
For Additional Information ContactMark Littlefield
972-518-6062
Manufacturer 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
FDA Determined
Cause 2		Other
ActionOn 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.
Quantity in Commerce3266 Worldwide, 2009 Domestically
DistributionNationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DIP
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