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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT i2000 System and ARCHITECT i2000 SR

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 Class 2 Recall
ARCHITECT i2000 System and ARCHITECT i2000 SR
see related information
Date Posted November 09, 2009
Recall Status1 Terminated on January 26, 2010
Recall Number Z-0132-2010
Recall Event ID 52833
Premarket Notification
510(K) Number
K983212 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology.
Code Information ARCHITECT i2000 System List Number 8C89-01; ARCHITECT i2000SR System System List Number 3M74-01 and 3M74-02; Wash Zone Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash Buffer 1 L List Number 6C54-58 and l0 L List number 6C54-88.
Recalling Firm/
Manufacturer
Abbott Laboratories, Inc
1921 Hurd Drive
PO Box 152020
Irving, Texas 75038-4313
Consumer Instructions No consumer action necessary
Manufacturer Reason
for Recall
Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action A product correction notice was issued to consignees on July 17, 2009. Field representatives were instructed to visit consignees, inspect cables and replace them.
Quantity in Commerce 4,526
Distribution Worldwide Distribution
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.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = ABBOTT LABORATORIES
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