| Date Initiated by Firm | April 30, 2007 |
|---|
| Date Posted | June 09, 2007 |
|---|
| Recall Status1 |
Terminated 3 on December 17, 2007 |
| Recall Number | Z-0920-2007 |
|---|
| Recall Event ID |
37796 |
| 510(K)Number | K060690 |
|---|
| Product Classification |
Enzyme immunoassay - Product Code LEG
|
| Product | Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyzer; Catalog No.04491041190. |
|---|
| Code Information |
Lots 144107, exp. 9/30/2007; 144166, exp. 1/31/2008, and 144208, exp. 6/30/2008 |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46250-0416
|
| For Additional Information Contact |
800-428-2336 |
|---|
Manufacturer Reason
for Recall | Probe Wash: Reported results may have a positive bias because inadequate analyzer probe wash instructions may result in carry-over from the following assays: Creatinine Kinase L and Creatine Kinase-MBL. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Consignees were issued a recall letter dated 4/30/07 instructing them to perform a R2 reagent probe wash when using CKL and CKMBL with the vancomycin or valproic acid assays. |
|---|
| Quantity in Commerce | 992 |
|---|
| 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 = LEG
|
|---|
