Recall Z-2171-2010 ยท NRP Sirolimus Test System
Abbott Laboratories
IMx Sirolimus Reagent Pack; 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 USA; list 5C91-2
| Date | Aug 3, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors. |
| Root cause | Other |
| Action | Abbott sent a "Product Recall" letter dated April 30, 2010, to all customers receiving the affected lot of reagent. The accounts were informed of the increased frequency of calibration errors, including: 157 Check 1 Out of Range, 161 Check 5 Out of Range, and 173 Mode 1 deviation Factor High. The accounts were requested to determine if they are currently using or have inventory of lot 802873106, discontinue use of and destroy any remaining inventory of the lot, and retain a copy of the letter for their laboratory records. Customers requiring additional information were directed to contact |
| Quantity | 466 kits |
| Distribution | Worldwide distribution: USA and countries including Puerto Rico, Argentina, Austria, Bahrain, Brazil, Canada, Chile, China, Croatia, Cyprus, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Jordan, Lebanon, Lithuania, Netherlands, Norway, Philippines, Poland, Russia, Panama, Sa |
| 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 |