Diasorin Inc. Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) reader) for use with Diastat Anti-Beta2 Glycoprotein ELISA assay kit.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
software version 12
Products Sold
software version 12
Diasorin Inc. is recalling Data reduction program written for a specific automated microtiter plate instrument (Bio-Tek ELx800) due to Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Data reduction Program written for specific sutomated microtiter plate insturment (Bio-Tek ELx800 reader) is faulty in that the positive result limit is to be greater than 15 U/ml, rather than greater than or equal to 15 U/ml.
Recommended Action
Per FDA guidance
Customers were sent notification letters and effectiveness check form. recommended users manually veify positve results (RSLT), 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
CT, MI, MT, UT
Page updated: Jan 10, 2026