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U.S. Department of Health and Human Services

Class 3 Device Recall TestPack Plus hCG Combo with On Board Controls (OBC)

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  Class 3 Device Recall TestPack Plus hCG Combo with On Board Controls (OBC) see related information
Date Initiated by Firm March 16, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on May 25, 2006
Recall Number Z-1392-05
Recall Event ID 31466
510(K)Number K965116  
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Product ABBOTT TestPack +Plus hCG Combo with On Board Controls (OBC), list number 7B34-16; the kit contains 20 reaction discs, Anti-beta hCG (Goat) and Anti-alpha hCG (Mouse, Monoclonal) coated; Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information list number 7B34-16, lot numbers 16006M200 and 19199M300
Recalling Firm/
Manufacturer		 Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
877-422-2688
Manufacturer Reason
for Recall		 False Positive results may be obtained with the identified lots of list 7B34-16 when using a negative patient sample or a negative control.
FDA Determined
Cause 2		 Other
Action Abbott notified their affiliates in all four countries via e-mail on 3/16/05. Each Abbott international country organization is responsible for translating the customer letter, contacting customers and determining the method of effectiveness checks based on their country requirements. The recall letters inform the accounts of the false positve results, and were requested to destroy any remaining inventory of the affected lots.
Quantity in Commerce 7607 kits
Distribution Canada, Germany, Hong Kong and Australia
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 = JHI and Original Applicant = ABBOTT LABORATORIES
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