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
- Company
- Diasorin Inc.
- Recall Initiated
- April 8, 2005
- Posted
- April 27, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0776-05
- Quantity
- 2104
- Firm Location
- Stillwater, MN
Reason for Recall
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).
Distribution
Nationwide including: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WV and Puerto Rico
Lot / Code Info
9850180E (expiration 08/02/2005); 9850180E/1 (expiration 08/02/2005); 9850180F (expiration 08/02/2005) and 9850190A (expiration 01/18/2006)
Root Cause
Other
Action Taken
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.