| Date Initiated by Firm | February 10, 2006 |
|---|
| Date Posted | February 28, 2006 |
|---|
| Recall Status1 |
Terminated 3 on June 23, 2006 |
| Recall Number | Z-0574-06 |
|---|
| Recall Event ID |
34590 |
| 510(K)Number | K912143 |
|---|
| Product Classification |
Fluorescence Polarization Immunoassay, Tobramycin - Product Code LFW
|
| Product | Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216. |
|---|
| Code Information |
Lot 56292625; exp. 05/31/07. |
| FEI Number |
1823260
|
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis
IN
46256-1025
|
| For Additional Information Contact |
800-428-2336 |
|---|
Manufacturer Reason
for Recall | May have tobramycin over-recovery at the trough level. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were notified via phone and faxed recall letter on or about 2/10/06. |
|---|
| Quantity in Commerce | 1806 kits |
|---|
| 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 = LFW
|
|---|
