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U.S. Department of Health and Human Services

Class 3 Device Recall IMx Rubella IgM Reagent Kit

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  Class 3 Device Recall IMx Rubella IgM Reagent Kit see related information
Date Initiated by Firm July 22, 2003
Date Posted August 13, 2003
Recall Status1 Terminated 3 on September 16, 2003
Recall Number Z-1129-03
Recall Event ID 26868
510(K)Number K931059  
Product Classification Enzyme Linked Immunoabsorbent Assay, Rubella - Product Code LFX
Product IMx Rubella IgM Reagent Kit, 100 tests, list 7A24-20; Abbott Laboratories, Abbott Park, IL 60064
Code Information list 7A24-20, lot 01687M300
Recalling Firm/
Manufacturer		 Abbott Laboratories HPD/ADD/GPRD
100/200 Abbott Park Road
Abbott Park IL 60064
For Additional Information Contact U.S. Customer Service
800-422-2688
Manufacturer Reason
for Recall		 The package insert contains incomplete information for the English text. Pages 4 and 5 are missing and pages 14 and 15 are duplicated.
FDA Determined
Cause 2		 Other
Action Recall letters dated 7/21/03 were sent to the accounts by Federal Express Priority on 7/22/03, informing the accounts of the error in the package insert and instructing them to discontinue using the incorrect insert (commodity 34-0284/R8) and used the enclosed revised insert (commodity 34-2915/R9) with lot 01687M300. The revised package insert 34-2915/R9 was inadvertently omitted from the first mailing and was sent on 7/23/03.
Quantity in Commerce 423 kits
Distribution California, Michigan, North Carolina, Ohio, Tennessee, Wisconsin, Georgia, Illinois, Kentucky, Massachusetts and Texas, and internationally to Columbia, Peru, Uruguay, Brazil, San Salvador, Canada, Germany, Singapore, Korea and Honduras
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 = LFX and Original Applicant = ABBOTT LABORATORIES
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