Recall Z-2059-2008 ยท DIP Enzyme Immunoassay, Diphenylhydantoin
Abbott Laboratories Inc.
ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
| Date | Sep 16, 2008 (initiated Feb 15, 2008) |
| Status | Terminated |
| Reason | 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 | 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 ques |
| Quantity | 3266 Worldwide, 2009 Domestically |
| Distribution | Nationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993026 | ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS Syva Co., Jan 27, 2000 |