Z-2059-2008

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

Name: Z-2059-2008 ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human...
Creator: Abbott Laboratories Inc.
Published: 2008-02-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2008-02-15 / Terminated / root cause: labeling and UDI

FDA source

Abbott Laboratories Inc. began a recall of ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma on 2008-02-15. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2059-2008
Status: Terminated
Initiated: 2008-02-15
Posted: 2008-09-16
Terminated: 2012-03-23
Recalling firm: Abbott Medical
Product: ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
Product code: DIP Enzyme Immunoassay, Diphenylhydantoin
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
Root cause tag: labeling and UDI
FDA root cause: Other
Action: 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.
Quantity in commerce: 3266 Worldwide, 2009 Domestically
Distribution: Nationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore
Product codes and lots: Lot Numbers:42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00

Product code DIP

K993026Class IIAbbot Aeroset Phenytoin Assay & Abbot Aeroset Phenytoin CalibratorsSyva Co. / cleared 2000-01-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)