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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
IMx Sirolimus Reagent Pack		see related information
Date Posted February 15, 2007
Recall Number Z-0501-2007
Product 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 USA
Code Information list 5C91-21, lots 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Reason for
Recall		 The sirolimus values may shift higher after storage at 2-8¿C or after one freeze/thaw cycle of specimens.
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 in Commerce 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, Germany, Lithuania, Saudi Arabia, Jordan, Israel, Lebanon, Kuwait, Oman, Qatar, UAE, Egypt, Mexico, Guatemala, Venezuela, Colombia, Peru, Chile, Argentina, Brazil, El Salvador, Canada, Ireland, United Kingdom, Sweden, Netherlands, Belgium, France, Austria, Czech Republic, and Switzerland
 
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