| Date Initiated by Firm | April 30, 2007 |
|---|
| Date Posted | June 09, 2007 |
|---|
| Recall Status1 |
Terminated 3 on December 17, 2007 |
| Recall Number | Z-0919-2007 |
|---|
| Recall Event ID |
37796 |
| 510(K)Number | K060586 |
|---|
| Product Classification |
Enzyme immunoassay - Product Code LEH
|
| Product | Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Catalog No.04491050190. |
|---|
| Code Information |
Lots 144174, exp. 7/31/2007; 144195, exp. 9/30/2007 and 144207, exp. 11/30/2007. |
| FEI Number |
1823260
|
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 | 662 |
|---|
| 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 = LEH
|
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