Recall Z-1596-2010 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Abbott Diagnostics International, Ltd.
ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum.
| Date | May 19, 2010 (initiated Dec 30, 2009) |
| Status | Terminated |
| Reason | There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay. |
| Root cause | Pending |
| Action | Direct accounts (hospitals, private laboratories, and other institutions) were sent a Product Correction letter, dated 12/30/2009. The letter identified the affected product, explained the issue and patient impact, and listed several necessary actions. Customers were instructed to follow one of 4 different alternatives to protect the integrity of test results. The letter is to be retained for laboratory records and a copy should be sent to other laboratories that kits were forwarded to. Questions regarding this information should be directed to Customer Service at 1-877-4ABBOTT. |
| Quantity | 1,326 |
| Distribution | Nationwide Distribution -- Including Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063329 | ABBOTT ARCHITECT HAVAB-M Abbott Laboratories, Apr 16, 2007 |