|
Class 2 Device Recall AccuChek |
![see related information](../images/related-info.gif) |
Date Initiated by Firm |
February 10, 2006 |
Date Posted |
February 28, 2006 |
Recall Status1 |
Terminated 3 on February 08, 2007 |
Recall Number |
Z-0566-06 |
Recall Event ID |
34485 |
510(K)Number |
K010362
|
Product Classification |
Glucose Dehydrogenase, Glucose - Product Code LFR
|
Product |
Accu-Chek Comfort Curve blood glucose test strips; Reference numbers 12030420001, 12030373001, 12030381001, 12030365001, 04388208001, 04388186001 and 03000141001. (Sold in the United States). |
Code Information |
All lots. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-440-3638
|
Manufacturer Reason for Recall |
There may be a thin piece of plastic across the mouth of the vial, preventing the cap from sitting snugly onto the vial and, if present, this situation will cause erroneously low or high blood glucose readings.
|
FDA Determined Cause 2 |
Other |
Action |
Notifications (letters) dated 2/10/06 were sent to healthcare professionals, retail pharmacies, hospitals and mail order firms asking them to provide their customers with information instructing the users to inspect their strip vials and to not use strips from defective vials. Mail order accounts were instructed to forward the recall notification to end users. |
Distribution |
Nationwide, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Ecuador, England, France, Germany, Hong Kong, India, Indonesia, Japan, Malaysia, Mexico, New Zealand, Pakistan, Panama, Peru, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Taiwan and Thailand. |
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 = LFR and Original Applicant = ROCHE DIAGNOSTICS CORP.
|
|
|
|