| Date Initiated by Firm | March 15, 2010 |
|---|
| Date Posted | August 02, 2010 |
|---|
| Recall Status1 |
Terminated 3 on August 03, 2010 |
| Recall Number | Z-2117-2010 |
|---|
| Recall Event ID |
55226 |
| 510(K)Number | K051087 |
|---|
| Product Classification |
Reaction Vessels - Product Code JJE
|
| Product | Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in vitro diagnostic use. |
|---|
| Code Information |
Lot numbers NH20-309-09, NH20-330-09, NH20-337-09, and NH20-001-10 |
| 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 | Technical Solutions Center
800-441-9250 |
|---|
Manufacturer Reason
for Recall | Vessel pick up errors and vessel jams when the vessel is being loaded. The error halts the instrument and disrupts processing. Vessel flange is thin. |
|---|
FDA Determined
Cause 2 | Process design |
|---|
| Action | Siemens Healthcare Diagnostics issued an Urgent Field Safety Notice dated March 2010 informing users of the potential problem, to discard any remaining product, and if needed, to request a replacement lot. |
|---|
| Quantity in Commerce | 5544 bags |
|---|
| Distribution | Worldwide distribution: USA, Canada, Europe, Japan, Korea, and New Zealand. |
|---|
| 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
|
|---|
