FDA Medical Device Recalls (openFDA)
Abbott Laboratories HPD/ADD/GPRD: IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Recall number
- Z-0230-04
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Product
- IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
- Status
- Terminated
- Initiated
- 2003-11-13
- Posted
- 2003-12-17
- Terminated
- 2004-10-29
- Reason
- Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
- Root cause
- Other
- Action
- Device correction recall initiated by letters dated 11/12/03. Letters were sent to all current IMx Tacrolimus II customers worldwide, advising them that calibration errors and controls out of range be the result of variance with the sample pretreatment steps listed in the package insert, and that the protein interference data in the insert is not representative of assay performance (12% when it should state less than 22% error) . A Customer Training Guide was included in the letter, outlining steps to aid the assay user in performing the pretreatment step and listing the most common deviations that can impact results.
- Quantity
- not lot specific
- Distribution
- Nationwide and internationally to Guatemala, Venezuela, Columbia, Peru, Chile, Australia, Panama, Argentina, Puerto Rico, Dominican Republic, Canada, Germany, New Zealand, England, Japan, Singapore, Thailand, Korea and Costa Rica.
- Lot, serial or model codes
- All lot numbers
- 510(k) numbers
- not on file
- PMA numbers
- ["P970007"]
- Product code
- MLM
- Firm FEI
- 1415939
- Firm city
- Abbott Park
- Firm state
- IL
- 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