Diasorin Inc. Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader with use of Diastat Anti-Mitochondrial Antibody Kit
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Software version 12
Products Sold
Software version 12
Diasorin Inc. is recalling Data reduction program written specifically for Bio-Tek ELx800 automated microtiter plate reader wit due to The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800 reader) was found to be faulty. This program is used to calculate the cut off values for Diastat Anti-Mitochondrial Antibody Kit. Program should include a borderline specification to indicate repeat testing is needed.
Recommended Action
Per FDA guidance
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.
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, CT, KS, MA, WA
Page updated: Jan 10, 2026