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U.S. Department of Health and Human Services

Class 2 Device Recall IMx Sirolimus Reagent

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 Class 2 Recall
IMx Sirolimus Reagent
see related information
Date Posted August 03, 2010
Recall Status1 Terminated on May 13, 2011
Recall Number Z-2171-2010
Recall Event ID 55557
Premarket Notification
510(K) Number
K042411 
Product Classification Sirolimus Test System - Product Code NRP
Product 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 5C91-21 The IMx Sirolimus assay is an in vitro reagent system for the quantitative determination of sirolimus in human whole blood as an aid in the management of renal transplant patients receiving sirolimus therapy.
Code Information Lot number 802873106, Expiry Date May13, 2010
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall
IMx Sirolimus reagent lot 802873106 has exhibited an increased frequency of calibration errors.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
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 Abbott Customer Service at 1-877-422-2688. Customers outside of the U.S., please contact your local Customer Service Representative.
Quantity in Commerce 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, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = NRP and Original Applicant = AXIS-SHIELD LTD.
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