Abbott Laboratories HPD/ADD/GPRD IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Laboratories HPD/ADD/GPRD
Lot Codes / Batch Numbers
All lot numbers
Products Sold
All lot numbers
Abbott Laboratories HPD/ADD/GPRD is recalling IMx Tacrolimus II Assay, list 3C10-20; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott due to Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inadequate instructions for use resulting in calibration errors and the protein interference data in the package insert is not representative of assay performances.
Recommended Action
Per FDA guidance
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.
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