Diasorin Inc. DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 Northwestern Avenue, Stillwater, MN 55082. Made in the United Kingdom.
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
Catalog no. 7800, lots FS1123 and FS2184
Products Sold
Catalog no. 7800, lots FS1123 and FS2184
Diasorin Inc. is recalling DiaSorin Anti-Cardiolipin IgA ELISA Kit, catalog no. 7800. Manufactured for: DiaSorin Inc. 1951 No due to DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
DiaSorin Anti-Cardiolipin IgA Kit, catalog no. 7800, positive control was on the low limit of the acceptable range (16-35 U/mL).
Recommended Action
Per FDA guidance
Customers were notifed of the product and the problem and were advised to destroy any remaining inventory and replacements were offered.
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
GA, KS, MT, NY
Page updated: Jan 10, 2026