Recall Z-0501-2007 ยท NRP Sirolimus Test System
Abbott Laboratories MPG
IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 US
| Date | Feb 15, 2007 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. |
| Root cause | Other |
| Action | Abbott initiated a field correction recall by letter dated 8/11/06 to all customers receiving the affected reagent. The accounts were informed of the shift in sample values after storage at 2-8*C or with freeze thaw of specimens with the affected lots of reagents. The accounts were requested to review the revised sample handling information included in the attachment to the letter with their laboratory personnel and retain a copy of the letter and attachment for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688. |
| Quantity | 2,800 kits |
| Distribution | Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealand, Norway, Italy, Portugal, Spain, Greece, Panama, Hungary, Slovakia, Russia, Romania, Cyprus, Germa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042411 | ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY Axis-Shield , Ltd., Apr 7, 2005 |