| Date Initiated by Firm |
May 18, 2005 |
| Date Posted |
July 12, 2005 |
| Recall Status1 |
Terminated 3 on December 12, 2005 |
| Recall Number |
Z-0977-05 |
| Recall Event ID |
31949 |
| 510(K)Number |
K022171
|
| Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
| Product |
ACCU-CHEK Compact Care Kit; catalog number 3149137. |
| Code Information |
All units. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-858-8072
|
Manufacturer Reason
for Recall |
The meter may self-start without a sample having been applied and report erroneous results without an error message if the nose cover is not properly snapped in place and the undosed test strip is bent upwards while the meter is waiting for the sample, or if excess control solution or blood has been applied to the test strip.
|
FDA Determined
Cause 2 |
Other |
| Action |
A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future. |
| Distribution |
Nationwide. |
| 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 = NBW and Original Applicant = ROCHE DIAGNOSTICS CORP.
|
