Diasorin Inc. Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with use of PRO-Trac Tacrolimus ELISA kit
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
version 12
Products Sold
version 12
Diasorin Inc. is recalling Version 12 software program written for the Bio-Tek ELx800 automated microtiter plate reader with us due to The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was f. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.
Recommended Action
Per FDA guidance
Customers were sent notification letters and effectiveness check form. recommended users manually veify results using product insert specifications.
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 noticeDistribution
As reported by FDA
CA, FL, KY, WA, DC
Page updated: Jan 10, 2026