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U.S. Department of Health and Human Services

Class 3 Device Recall XSYSTEMS Multiconstituent Controls for Abused Drug Assays

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  Class 3 Device Recall XSYSTEMS Multiconstituent Controls for Abused Drug Assays see related information
Date Initiated by Firm June 27, 2005
Date Posted September 14, 2005
Recall Status1 Terminated 3 on January 18, 2006
Recall Number Z-1539-05
Recall Event ID 32540
510(K)Number K873183  
Product Classification Drug Mixture Control Materials - Product Code DIF
Product XSYSTEMS AxSYM Multiconstituent Controls for Abused Drug Assays, list 9687-12; Abbott laboratories, Abbott Park, IL 60064 USA
Code Information lot numbers 17270M100 and 18177M300
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 The XSYSTEMS Multiconstituent Controls accessory insert (commodity number 34-3067/R6) does not contain the correct control ranges for the AxSYM Opiates assay.
FDA Determined
Cause 2		 Other
Action On 6/27/05, Abbott sent the customer letter via FedEx to all XSYSTEMS Multiconstituent Controls customers that received List Number 9687-12 lots 17270M100 and/or 18177M300 and/or AxSYM Opiates reagents (List Number 3B25-20) since June 01, 2004. The letters explained that the multiconstituent control ranges for morphine were not updated in the MCC Accesory insert at the same time they were updated in the AxSYM Opiates reagent package insert in 2004. The accounts were requested to review their current control ranges for the AxSYM Opiates assay, and verify that they are using either the control ranges in the AxSYM Opiates reagent package insert or control ranges established by their facility. They were also instructed to follow their facility''s normal policies and procedures for communicating with health care providers served by their laboratory. The accounts were requested to complete and return the enclosed reply sheet acknowledging the receipt of the letter and the dissemination of the letter to the laboratory manager/supervisor responsible for the assays.
Quantity in Commerce 4151 kits
Distribution Nationwide, including Puerto Rico, and internationally to Argentina, Australia, Barbados, Bermuda, Brazil, Canada, Cayman Island, Chile, China/Hong Kong, Columbia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Germany, Honduras, Jamaica, Korea, Mexico, New Zealand, Panama, Peru, Singapore, St. Vincent, Thailand, Trinidad and Taiwan
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 = DIF and Original Applicant = ABBOTT LABORATORIES
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