Recall Z-0068-2011 ยท MLM Enzyme Immunoassay, Tracrolimus
Abbott Laboratories
Architect Tacrolimus Reagent Kit; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacrolimus in human whole blood; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 1L77-25 The Architect Tacrolimus assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of tacro
| Date | Oct 15, 2010 (initiated Sep 7, 2010) |
| Status | Terminated |
| Reason | There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode. |
| Root cause | Other |
| Action | Abbott Laboratories sent a "Product Recall Immediate Action Required" letter dated September 7, 2010, to all customers. The letter described product, problem and action to be taken by customers. The customers were instructed to determine if they are currently using and/or have inventory of lot 86599M500; discontinue use of and destroy any remaining inventory; inform and provide copies of letter to other laboratories if appropriate; retain the letter for laboratory records and complete and return the Customer Reply Immediate Action Required form via fax at 1-800-777-0051 or email QAGCO@abbott. |
| Quantity | 1,995 kits |
| Distribution | Worldwide distribution: USA and countries including Puerto Rico, Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Egypt, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 Fujirebio Diagnostics,Inc., Aug 1, 2007 |