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U.S. Department of Health and Human Services

Class 2 Device Recall Complement C4, antigen, antiserum, control

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  Class 2 Device Recall Complement C4, antigen, antiserum, control see related information
Date Initiated by Firm May 16, 2018
Create Date July 19, 2019
Recall Status1 Terminated 3 on August 16, 2021
Recall Number Z-1992-2019
Recall Event ID 83189
510(K)Number K983356  
Product Classification Complement c4, antigen, antiserum, control - Product Code DBI
Product C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human
serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent,
forming an immune complex. The immune complex causes an increase in light scattering, measured by reading turbidity at 604 nm, which correlates with the concentration of C4 in the sample.
Code Information All IFU's
Recalling Firm/
Manufacturer		 Abbott Laboratories, Inc
1921 Hurd Dr
Irving TX 75038-4313
For Additional Information Contact Mr. Albert A. Chianello
877-422-2688
Manufacturer Reason
for Recall		 An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued letters dated 5/16/2019 via FedEx priority overnight express on 5/16/2019 to the U.S. customers. For OUS, each country organization needs to establish their own method of notification, which normally consists of mailings or customer visits.
Quantity in Commerce 8,037 kits
Distribution Distribution was nationwide, including Puerto Rico. There was government/military distribution. Foreign distribution was made to Canada, Albania, Algeria, Andorra, Argentina, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovi, Botswana, Brazil, Brunei, Bulgaria, Chile, China, Costa Rica, Croatia, Curacao (Netherlands Antilles), Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, Ecuador, Egypt, Estonia, Finland, France, Gaza & Jericho, Germany, Greece, Greenland, Honduras, Hong Kong, India, Iraq, Ireland, Israel, Italy, Ivory Coast, Jamaica, Jordan, Kazakhstan, Kenya, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya. Lithuania, Luxembourg, Macedonia, Malaysia, Maldives, Mali, Mauritania, Mexico, Moldova, Montenegro, Morocco, Namibia, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Yemen, Romania, Russia, Rwanda, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Trinidad & Tobago, Tunisia, Turkey, Turks and Caicos, Tunisia, UAE, United Kingdom, Uruguay, and Viet Nam.
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 = DBI and Original Applicant = ABBOTT LABORATORIES
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