Diasorin Inc. Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use with the ENA 6 Screen ELISA kit assay.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
software versions 9 thru 12
Products Sold
software versions 9 thru 12
Diasorin Inc. is recalling Software written for a specific automated microtiter plate instrument, Bio-Tek ELx800 reader for use due to An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An error in the Bio-Tek ELx800 microplate reader programming specifications for the ENA screen Assay exists in that an equivocal (borderline) zone is missing.
Recommended Action
Per FDA guidance
Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.
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
AR, CT, FL, NY, TN, TX, WA
Page updated: Jan 10, 2026