Abbott Laboratories Inc. ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
Brand
Abbott Laboratories Inc.
Lot Codes / Batch Numbers
Lot Numbers:42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
Products Sold
Lot Numbers:42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
Abbott Laboratories Inc. is recalling ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoi due to An Abbott investigation has determined that the phenytoin reagent does not maintain an onboard stability of 28 days as stated in the phenytoin package. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026