| Class 2 Device Recall IMx Sirolimus Reagent Pack | |
Date Initiated by Firm | August 11, 2006 |
Date Posted | 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
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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 IL 60064-3502
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For Additional Information Contact | Abbott Customer Support 877-422-2688 |
Manufacturer Reason for Recall | The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens. |
FDA Determined Cause 2 | 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 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 |
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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.
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510(K) Database | 510(K)s with Product Code = NRP
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