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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT iVancomycin Reagent

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  Class 2 Device Recall ARCHITECT iVancomycin Reagent see related information
Date Initiated by Firm September 13, 2010
Date Posted December 16, 2010
Recall Status1 Terminated 3 on June 22, 2011
Recall Number Z-0629-2011
Recall Event ID 56757
510(K)Number K072036  
Product Classification Calibrators, drug specific - Product Code DLJ
Product ARCHITECT iVancomycin Reagent; an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 USA; list 1P30-25
The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.
Code Information list 1P30-25, all lots
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall		 The assay may produce falsely elevated vancomycin results. Inaccurate test results may result in inappropriate patient treatment.
FDA Determined
Cause 2		 Other
Action Abbott Laboratories issued a Product Correction letters dated September 13 and 15, 2010 to all customers that received ARCHITECT iVancomycin reagents in the last 12 months. In the September 13, 2010 letter, the accounts were informed of the falsely elevated results and were instructed to continue to follow all sample handling instruction in the package insert and to take the following additional actions to mitigate the risk of obtaining an incorrect result: 1. After following the primary tube manufacturer's recommended centrifugation instructions transfer serum or plasma for all specimens to a microcentrifuge tube for centrifugation at 150,000-300,000 g-minutes, following centrifugation guidelines in the chart in the letter. 2. Prior to testing, transfer the serum or plasma to a sample cup or secondary tube for testing. Care must be taken to transfer only the clarified specimen and not the lipemic material or pellet. The accounts were also requested to complete and fax back to Abbott the enclosed customer reply sheet, acknowledging the receipt and understanding of the recall. On September 15, 2010, Abbott discovered that the calculation for the determination of RCF (xg) given in the September 13, 2010 letter was incorrect. Incorrect Calculation previously provided: Relative Centrifugal Force (RCF) = 0.0000118 x rotational radius in centimeters x RPM2 Correct Calculation within revised letter: Relative Centrifugal Force (RCF) = 0.00001118 x rotational radius in centimeters x RPM2 Abbott stopped distribution of the previous letter and initiated redistribution of the revised letter to all impacted customers, globally, on September 15, 2010. Additionally, all customers which had already received the initial letter were sent a cover letter identifying the error. Customers can contact Abbott at 1-877-422688 about this action.
Quantity in Commerce 2,411 kits
Distribution Worldwide Distribution: Throughout USA, including Puerto Rico, and the countries of: Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Oman, Pakistan, Poland, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom 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 = DLJ and Original Applicant = BIOKIT S.A.
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