DiaSorin ETI-HA-IGMK PLUS Enzyme Immunoassay for the Detection of IgM Antibody to Hepatitiis A Virus (IgM anti-HAV) in H
FDA device recall Z-0776-05 · posted 2005-04-27 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- 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).
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LOL
- Quantity affected
- 2104
- 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
- Date initiated
- 2005-04-08
- Date posted
- 2005-04-27
- Date terminated
- 2006-07-22
- Location
- Stillwater, MN
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