Diasorin Inc. Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) automated microtiter plate reader with use of Diastat Anti-Thyroglobulin Assay (manufacturer part #7700).
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
software version 9 thru 12
Products Sold
software version 9 thru 12
Diasorin Inc. is recalling Data reduction program software written specifically for Bio-Tek ELx800 (DiaSorin part # 15713) auto due to The data reduction program written for a specific automated microtiter plate reader (Bio-Tek ELx800) was found to be faulty. This program is used to . 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 reader (Bio-Tek ELx800) was found to be faulty. This program is used to calculate the cut off values for the Diastat Anti-Thyroglobulin Kit assay. The negative Control Upper Limit should be less than 0.95, rather than less than 1.0.
Recommended Action
Per FDA guidance
Customers were sent a notification letter directing customers to check historical data for negative control results reading greater than 0.95 but less than 1.0. These results are invalid and patient results should not have been reported. Customers are instructed to verify negative control manually until new software version is installed. An effectiveness check form is requested to be returned.
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, MA, NY, TX
Page updated: Jan 10, 2026