FDA Medical Device Recalls (openFDA)
Abbott Laboratories Inc.: ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
- Recall number
- Z-2059-2008
- Recalling firm
- Abbott Laboratories Inc.
- Product
- ABBOTT Clinical Chemistry Phenytoin, List Number: 1E07-20, is used for the quantitation of phenytoin in human serum or plasma.
- Status
- Terminated
- Initiated
- 2008-02-15
- Posted
- 2008-09-16
- Terminated
- 2012-03-23
- 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 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
- 3266 Worldwide, 2009 Domestically
- Distribution
- Nationwide and Worldwide to: Australia, Canada, Chile, Germany, Hong Kong, New Zealand, Panama, Singapore, Uruguay, Singapore
- Lot, serial or model codes
- Lot Numbers:42036HW00, 44084HW00, 45051HW00, 47055HW00, 50039HW00, 52013HW00, 55015HW00, 59088HW00
- 510(k) numbers
- ["K993026"]
- PMA numbers
- not on file
- Product code
- DIP
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28