Recall Z-2413-2011 ยท LOL Hepatitis A Test (Antibody And Igm Antibody)
Abbott Laboratories
ARCHITECT HAVAB-M Assay 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; Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA, List 6L21-25
| Date | Jun 6, 2011 (initiated Apr 20, 2011) |
| Status | Terminated |
| Reason | The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results. |
| Root cause | Nonconforming Material/Component |
| Action | Abbott Laboratories issued a Product Recall letters dated April 20, 2011 to all affected customers that received ARCHITECT HAVAB-M reagent, lot 93794HN00. The letters informed the accounts of the increased grayzone and/or reactive results and were instructed to discontinue use of the lot and destroy any remaining inventory of the lot according to laboratory procedures. If the account did not have an alternate lot of reagent, they were told to continue using the recalled lot until their lab receives the replacement lot, and to perform supplemental testing with another HAVAB-M method to conf |
| Quantity | 788 kits |
| 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 |