|
Class 2 Device Recall IMx Total BhCG Reagent |
|
Date Initiated by Firm |
April 10, 2007 |
Date Posted |
July 12, 2007 |
Recall Status1 |
Terminated 3 on February 14, 2012 |
Recall Number |
Z-1069-2007 |
Recall Event ID |
37920 |
510(K)Number |
K935673
|
Product Classification |
B-hCG In Vitro Diagnostic - Product Code JHI
|
Product |
IMx Total B-hCG Reagent is composed of one bottle of Anti B-hCG Coated Microparticles, one bottle of Anti B-hCG Alkaline Phosphatase Conjungate, one bottle of 4-Methylumbelliferyl Phosphate and one bottle of Specimen Diluent. |
Code Information |
46810Q100, 49118Q100, 49555Q100 |
Recalling Firm/ Manufacturer |
Abbott Diagnostic International, Ltd. 30 Bo Cruce Davila Barceloneta PR 00617-3009
|
For Additional Information Contact |
Customer Support 877-422-2688
|
Manufacturer Reason for Recall |
An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background effect is magnified potentially yelding false positive results for pregnancy and or Dilution Inaccuracy.
|
FDA Determined Cause 2 |
Other |
Action |
The 4/10/2007 Product Recall Letter was sent to all customers who received the affected lots. |
Quantity in Commerce |
3176 kits |
Distribution |
Worldwide, including USA, PR, USVI, CANADA, MEXICO, GUATEMALA, COSTA RICA, COLOMBIA, ECUADOR, PERU, CHILE, URUGUAY, ARGENTINA, BRAZIL, DOMINICAN REPUBLIC, EL SALVADOR, GERMANY, JAPAN, SINGAPORE, HONG KONG, TAIWAN, THAILAND, SOUTH KOREA, AUSTRALIA, NEW ZEALAND, HONDURAS, TRINIDAD & TOBAGO, GRENADA, ST. VINCENT, ST. LUCIA, ANTIGUA, BARBADOS, CURACAO, BRITISH VIRGIN ISLANDS, BAHAMAS, PANAMA, and CAYMAN ISLANDS. |
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
|
|
|
|