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U.S. Department of Health and Human Services

Class 3 Device Recall ABBOTT TestPack Plus hCG Combo

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  Class 3 Device Recall ABBOTT TestPack Plus hCG Combo see related information
Date Initiated by Firm August 07, 2005
Date Posted August 24, 2005
Recall Status1 Terminated 3 on March 27, 2006
Recall Number Z-1399-05
Recall Event ID 32895
510(K)Number K903219  
Product Classification Visual, Pregnancy Hcg, Prescription Use - Product Code JHI
Product ABBOTT TestPack +Plus hCG Combo, list 3A60-16; the kit contains 20 reaction discs, anti-beta hCG (Goat) and anti-alpha hCG (Mouse, Monoclonal) coated, and 20 transfer pipettes; Abbott Laboratories, Abbott Park, IL 60064 USA
Code Information list 3A60-16, lot 17597M200, exp. 10/25/05
Recalling Firm/
Abbott Laboratories MPG
100 Abbott Park Rd
Abbott Park IL 60064-3502
For Additional Information Contact Abbott Customer Support
Manufacturer Reason
for Recall
False Positive results may be obtained with the identified lot of list 3A60-16 when using a negative patient sample or a negative control.
FDA Determined
Cause 2
Action Abbott notified their affiliates in all eight countries via e-mail on 8/7/05. 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 positive results, and were requested to return any remaining inventory of the affected lots to Abbott in Germany.
Quantity in Commerce 3049 kits
Distribution This product is not distributed in the U.S. It was distributed internationally to Canada, Germany, Honduras, Nicaragua, the Bahamas, the Philippines (via Singapore), New Zealand, and Uruguay
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