| Date Initiated by Firm | June 16, 2009 |
|---|
| Date Posted | March 08, 2010 |
|---|
| Recall Status1 |
Terminated 3 on November 30, 2010 |
| Recall Number | Z-1017-2010 |
|---|
| Recall Event ID |
52958 |
| 510(K)Number | K051087 |
|---|
| Product Classification |
in vitro diagnostic - Product Code JJE
|
| Product | Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic. |
|---|
| Code Information |
Lot number 09061AA exp 2010-03-02 |
| FEI Number |
2517506
|
Recalling Firm/
Manufacturer |
Siemens Healthcare Diagnostics, Inc.
500 GBC Drive, Mailstop 514
PO BOX 6101
Newark
DE
19714-6101
|
| For Additional Information Contact | Customer Service Center
800-241-0420 |
|---|
Manufacturer Reason
for Recall | Incorrect result: patient sample BUN results reported may be higher or lower than actual level. |
|---|
FDA Determined
Cause 2 | Nonconforming Material/Component |
|---|
| Action | Siemens issued an Urgent Field Safety Notice dated 6/16/09 to all affected customers instructing them to discontinue use of the Dimension Vista BUN Flex reagent cartridge lot 09061AA. |
|---|
| Quantity in Commerce | 1254 cartons |
|---|
| Distribution | Worldwide distribution: USA, Australia, Canada, Germany, Japan, and Korea. |
|---|
| 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
|
|---|
