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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT Reaction Vessel

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 Class 2 Recall
ARCHITECT Reaction Vessel
see related information
Date Posted May 27, 2009
Recall Status1 Terminated on November 04, 2010
Recall Number Z-1392-2009
Recall Event ID 51254
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; Abbott Laboratories, Abbott Park, IL 60064; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis.
Code Information Product Number: 7C15-01; Lot Numbers: 68446P100, 69061P100, 69283P100, 68487P100, 69063P100, 69284P100, 68488P100, 69082P100, 69340P100, 68489P100, 69176P100, 69341P100, 68491P100, 69177P100, 69342P100, 68492P100, 69178P100, 69353P100, 68511P100, 69179P100, 69433P100, 68513P100, 69180P100, 69434P100, 68515P100, 69205P100, 69435P100, 68516P100, 69206P100, 69436P100, 68553P100, 69207P100, 69438P100, 69006P100, 69208P100, 69439P100, 69007P100, 69209P100, 69521P100, 69008P100, 69266P100, 69522P100, 69009P100, 69267P100, 69523P100, 69010P100, 69280P100, 69526P100, 69058P100, 69281P100, 69527P100, 69060P100, 69282P100 and 69660P100, 68306P100, 68389P100, 68390P100, 68391P100, 68392P100, 68393P100, 69684P100, 73657P100, 73742P100, 74114P100, 74115P100, 74117P100, 74235P100, 74277P100 and 74283P100. The recall was expanded to include an additional 40 lots on 12/7/09: 62616P100, 62756P100, 65386P100, 65388P100, 65740P100, 68007P100, 68097P100, 68119P100, 68241P100, 69683P100, 69686P100, 70421P100, 70431P100, 70563P100, 70565P100, 70598P100, 70601P100, 71077P100, 71092P100, 71168P100, 71234P100, 71235P100, 71239P100, 71304P100, 71447P100, 71448P100, 71450P100, 71451P100, 71515P100, 71519P100, 71550P100, 71554P100, 71555P100, 71558P100, 72252P100, 72293P100, 73319P100, 73464P100, 78387P100, and 80275P100.
Recalling Firm/
Manufacturer
Abbott Laboratories
100 Abbott Park Rd
Abbott Park, Illinois 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall
Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Consignees were contacted by phone and sent an "Urgent Field Safety Notice Product Recall" dated February 26, 2009. The letter informed users of the problem and detailed how to identify and discard the affected product. In addition, Abbott Laboratories asked the consignees to send a copy of the letter to any laboratory to which they may have forwarded any of affected lots. Abbott sent a second letter dated May 12, 2009 informing consignees of a recall expansion of additional affected lots. The recall was again expanded on 12/17/09 for an addtional 40 lots of reaction vessels. For additional information, contact Abbott Labs at 1-877-4ABBOTT.
Quantity in Commerce 27,163 cartons
Distribution Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway,Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia.
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.
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