| Date Initiated by Firm | December 15, 2003 |
|---|
| Date Posted | January 10, 2004 |
|---|
| Recall Status1 |
Terminated 3 on August 02, 2004 |
| Recall Number | Z-0328-04 |
|---|
| Recall Event ID |
27922 |
| 510(K)Number | K972733 |
|---|
| Product Classification |
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
|
| Product | Roche brand OMNI 9 clinical chemistry analyzer; catalog numbers GD0475, GD0475R and GD047591. |
|---|
| Code Information |
All units with software version 5.61 or below. |
| FEI Number |
1823260
|
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis
IN
46256-1025
|
| For Additional Information Contact |
800-526-2272 |
|---|
Manufacturer Reason
for Recall | If the sample volume is insufficient, the analyzer may issue erroneous results without any indication to the user that the problem is insufficient sample volume. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified by letter mailed on or about December 15, 2003. Customers are instructed to assure an adequate sample volume until new software becomes available. |
|---|
| Distribution | United States. |
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| 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 = JJE
|
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