Diasorin Inc. DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in Human Serum or Plasma Catalog No. P001925. Manufactured by: DiaSorin S.p.A. Saluggia, Italy
Brand
Diasorin Inc.
Lot Codes / Batch Numbers
9850180E (expiration 08/02/2005), 9850180E/1 (expiration 08/02/2005), 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006)
Products Sold
9850180E (expiration 08/02/2005); 9850180E/1 (expiration 08/02/2005); 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006)
Diasorin Inc. is recalling DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus due to The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the inst. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926).
Recommended Action
Per FDA guidance
Customers notified via mail, fax or email beginning 04/08/05 with a DiaSorin Customer Notification Letter which also contained a copy of the correct package insert. Distributors were directed to forward copies of the recall letter and correct package insert to their customers. Customers are instructed to destroy the incorrect insert.
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 noticePage updated: Jan 10, 2026