| Date Initiated by Firm | November 03, 2006 |
|---|
| Date Posted | November 29, 2006 |
|---|
| Recall Status1 |
Terminated 3 on June 11, 2015 |
| Recall Number | Z-0223-2007 |
|---|
| Recall Event ID |
36752 |
| Product Classification |
analytical laboratory data interface. - Product Code JQP
|
| Product | Roche Modular Drive (rchmdlri), analytical laboratory data interface. |
|---|
| Code Information |
Software Version: v8.00.0016, v8.00.0017, v7.00.0023 and v7.00.0024 |
| FEI Number |
3001451449
|
Recalling Firm/
Manufacturer |
Data Innovations, Inc.
120 Kimball Ave Ste 100
South Burlington VT 05403-6837
|
| For Additional Information Contact | Katharine Laddison
802-264-3420 |
|---|
Manufacturer Reason
for Recall | Software of modular driver may incorrectly report patient results as Quality Control Results |
|---|
FDA Determined
Cause 2 | Software change control |
|---|
| Action | Data Innovations notified users by email listserv and by letter dated 10/25/06. |
|---|
| Quantity in Commerce | 56 |
|---|
| Distribution | Nationwide and Canada. |
|---|
| 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.
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