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U.S. Department of Health and Human Services

Class 2 Device Recall IMx Sirolimus Reagent Pack

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  Class 2 Device Recall IMx Sirolimus Reagent Pack see related information
Date Initiated by Firm August 11, 2006
Date Posting Updated February 15, 2007
Recall Status1 Terminated 3 on January 18, 2008
Recall Number Z-0501-2007
Recall Event ID 37002
510(K)Number K042411  
Product Classification in vitro diagnostic - Product Code NRP
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/
Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
Manufacturer Reason
for Recall
The sirolimus values may shift higher after storage at 2-8¿C or after one freeze/thaw cycle of specimens.
FDA Determined
Cause 2
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
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NRP and Original Applicant = AXIS-SHIELD LTD.