Date Initiated by Firm |
November 19, 2004 |
Date Posted |
December 28, 2004 |
Recall Status1 |
Terminated 3 on June 07, 2005 |
Recall Number |
Z-0372-05 |
Recall Event ID |
30462 |
510(K)Number |
K012210
|
Product Classification |
System, Test, Blood Glucose, Over The Counter - Product Code NBW
|
Product |
ACCU-CHEK Inform meter; catalog No. 3035123. |
Code Information |
All units with firmware version 2.3 that have the OTE (other test entry) functionality enabled. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
|
For Additional Information Contact |
800-440-3638
|
Manufacturer Reason for Recall |
A firmware bug may allow test results from other systems, recorded into the INFORM system via the OTE functionality, to be reversed from positive to negative, and vice versa.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via a letter dated 11/19/04, which instructed them to discontinue using the OTE functionality. |
Quantity in Commerce |
4697 |
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.
|