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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i2000 Processing Module

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  Class 2 Device Recall ARCHITECT i2000 Processing Module see related information
Date Initiated by Firm March 28, 2007
Date Posted May 09, 2007
Recall Status1 Terminated 3 on September 25, 2007
Recall Number Z-0790-2007
Recall Event ID 37780
510(K)Number K983212  
Product Classification in vitro diagnostic - Product Code JJE
Product ARCHITECT i2000 Processing Module, for in vitro diagnostics, List Number 08C89-01; manufactured by Abbot Laboratories, Irving, TX.
Code Information All serial numbers.
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving TX 75038
Manufacturer Reason
for Recall		 If the ARCHITECT i2000/i2000sr System becomes contaminated with microbes generating folate-like by-products, the ARCHITECT Folate assay may experience calibration failures and/or shifts in results.
FDA Determined
Cause 2		 Other
Action Notification Letters were sent to all customers who received the ARCHITECT Folate Reagent on 03/28/07. Customers were provided with instructions on how to conduct a Wash Buffer Unload procedure and were requested to perform this action daily. Customers were also asked to contact their local Abbott Customer Support Rep to schedule an Internal Decontamination procedure on the ARCHITECT System. Firm recalling to the user (laboratory) level.
Quantity in Commerce n/a
Distribution Folate Reagent distributed to the following countries: Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Finland, France, Greece, Hungary, Ireland, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Russia, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Trinidad and Tobago, Turkey, UAE, United Kingdom. No US distribution.
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 = JJE and Original Applicant = ABBOTT LABORATORIES
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