Recall Z-2172-2010 ยท NRP Sirolimus Test System
Abbott Laboratories
Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25. The Architect Sirolimus assay is chemiluminescent microparticl
| Date | Aug 3, 2010 (initiated May 27, 2010) |
| Status | Terminated |
| Reason | The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors. |
| Root cause | Equipment maintenance |
| Action | Abbott sent a "Product Recall" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M10 |
| Quantity | 875 kits |
| Distribution | Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuani |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070822 | ARCHITECT SIROLIMUS ASSAY Fujirebio Diagnostics,Inc., Sep 28, 2007 |