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U.S. Department of Health and Human Services

Class 2 Device Recall ARCHITECT HAVABG Reagent Kit

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  Class 2 Device Recall ARCHITECT HAVABG Reagent Kit see related information
Date Initiated by Firm March 09, 2020
Create Date April 17, 2020
Recall Status1 Terminated 3 on February 11, 2021
Recall Number Z-1728-2020
Recall Event ID 85238
510(K)Number K113704  
Product Classification Hepatitis a test (antibody and igm antibody) - Product Code LOL
Product ARCHITECT HAVAB G Reagent Kit. List Number 6L27 25.
Code Information List Number 6L27 25. Lot No: 03429BE00, 06172BE00, 08073BE00, 10353BE00. UDI: (01)00380740011185 (17)200320(10)03429BE00, (01)00380740011185 (17)200604(10)06172BE00, (01)00380740011185 (17)200819(10)08073BE00, (01)00380740011185 (17)201023(10)10353BE00.
Recalling Firm/
Manufacturer		 Abbott Gmbh & Co. KG
Max-Planck-Ring 2
65205
Wiesbaden Germany
Manufacturer Reason
for Recall		 An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action Abbott GmbH notified customers on 03/09/2020 via "Product Recall Urgent  Immediate Action Required" letter. The recall letter identified the affected products and requested the customers to Immediately discontinue use of, and destroy, any remaining inventory of these ARCHITECT HAVABG reagent lots.
Quantity in Commerce 7,347 kits
Distribution US nationwide including the states of AL, AR, AZ, CA, CO, CT DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM NV, NY, OH, OK, OR, PA, RH, SC, TN, TZ, UT, VA, WA, WI, WV AND PR.
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 = LOL and Original Applicant = ABBOTT LABORATORIES
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