Date Initiated by Firm |
August 18, 2008 |
Date Posted |
January 15, 2009 |
Recall Status1 |
Terminated 3 on February 07, 2011 |
Recall Number |
Z-0528-2009 |
Recall Event ID |
49100 |
Product Classification |
Human Chorionic Gonadotropin Radioimmunoassay - Product Code JHI
|
Product |
Mainline hCG Accuracy Check, Mainline Technologies, Inc., Ann Arbor, MI; Catalog # 3c1001. |
Code Information |
Lots 50074 and 50075. |
Recalling Firm/ Manufacturer |
Mainline Technology, Inc. 3985 Research Park Dr Ann Arbor MI 48108-2282
|
For Additional Information Contact |
734-930-2043
|
Manufacturer Reason for Recall |
Lack of assurance of safety and efficacy: Unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expiration dates.
|
FDA Determined Cause 2 |
PMA |
Action |
Consignees were notified via a Medical Device Removal Notice dated 8/18/08 to locate, discontinue use, and return product along with a copy of the letter. The recall was extended to an additional product via letter dated 9/5/08. |
Quantity in Commerce |
not available |
Distribution |
Worldwide Distribution --- including USA and countries of Belgium and Switzerland. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
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