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U.S. Department of Health and Human Services

Class 2 Device Recall Architect Sirolimus Reagent Pack

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  Class 2 Device Recall Architect Sirolimus Reagent Pack see related information
Date Initiated by Firm May 27, 2010
Date Posted August 03, 2010
Recall Status1 Terminated 3 on July 15, 2011
Recall Number Z-2172-2010
Recall Event ID 55871
510(K)Number K070822  
Product Classification Sirolimus test system - Product Code NRP
Product Architect Sirolimus Reagent Pack; 100 test pack containing 1 bottle (8.0 mL) Anti-Sirolimus Coated Microparticles, 1 bottle (8.0 mL) Sirolimus Acridinium-labeled Conjugate in Citrate Buffer, and 1 bottle (10 mL) Assay Diluent containing saline; Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL 60064 USA; list 01L76-25.

The Architect Sirolimus assay is chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of sirolimus in human whole blood on the Architect i System, as an aid in the management of renal transplant patients receiving sirolimus therapy.
Code Information Lot 80162M100, Expiry Date May 03, 2011
Recalling Firm/
Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Customer Service
Manufacturer Reason
for Recall
The Architect Sirolimus assay lot 80162M100 is exhibiting higher than normal reports of barcode read errors.
FDA Determined
Cause 2
Equipment maintenance
Action Abbott sent a "Product Recall" letter dated May 27, 2010, to all customers receiving the affected lot of reagent. The customers were informed of the increased frequency of barcode read errors due to the print quality of the barcode label. The following error codes have been observed for some kits within the lot: 4000 - Unable to read reagent bar code in position (x) on (y) carousel, 0208 - Reagent carousel scan error, and 2011 - Extra reagent bottle detected in position (x) on (y) carousel. The customers were requested to determine if they are currently using or have inventory of lot 80162M100, 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 the U.S., please contact your local Customer Service representative.
Quantity in Commerce 875 kits
Distribution Worldwide distribution: USA including Puerto Rico, and countries of Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.
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 = FUJIREBIO DIAGNOSTICS, INC.