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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay

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  Class 2 Device Recall ARCHITECT HBsAg Qualitative Assay, ARCHITECT HBsAg Qualitative Confirmatory Assay see related information
Date Initiated by Firm December 18, 2012
Date Posted March 25, 2013
Recall Status1 Terminated 3 on July 31, 2013
Recall Number Z-0987-2013
Recall Event ID 63946
PMA Number P110029 
Product Classification Test, hepatitis b (b core, be antigen, be antibody, b core igm) - Product Code LOM
Product ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number 4P54

The ARCHITECT HBsAg Qualitative assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma and neonate serum.
Code Information All shipped out to this date
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact Customer Service
877-422-2688
Manufacturer Reason
for Recall		 Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR
FDA Determined
Cause 2		 No Marketing Application
Action The firm decided to correct the issue and and sent out Urgent Field Safety Notices to their customers dated 10/18/2012.
Quantity in Commerce 12
Distribution Nationwide Distribution including AZ, CA, FL, GA, HI, LA, MA, MD, MO, NJ, NY, PA, RI, TN, TX, UT, and WA.
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.
PMA Database PMAs with Product Code = LOM and Original Applicant = Abbott Laboratories
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