Date Initiated by Firm |
June 22, 2006 |
Date Posted |
August 05, 2006 |
Recall Status1 |
Terminated 3 on April 07, 2008 |
Recall Number |
Z-1356-06 |
Recall Event ID |
35022 |
510(K)Number |
K930979
|
Product Classification |
Blood Glucose Meter - Product Code CGA
|
Product |
ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 2137500; Ref. no. 0385633001 with meter model no. 768. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46250-0416
|
For Additional Information Contact |
800-440-3638
|
Manufacturer Reason for Recall |
The meter gives an error message that can "actually" mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error.
|
FDA Determined Cause 2 |
Other |
Action |
A recall notification letter dated April 24, 2006 was sent to each customer alerting them to the fact that this error code has a dual meaning. New software will be installed in all meters when it becomes available. |
Quantity in Commerce |
55,189 meters (for all Recalls Z-1354-1371-06) |
Distribution |
Worldwide, USA, Germany, Guam, North Mariana Islands, Panama and Virgin 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 = CGA and Original Applicant = BOEHRINGER MANNHEIM CORP.
|