| Date Initiated by Firm | May 08, 2003 |
|---|
| Date Posted | October 15, 2003 |
|---|
| Recall Status1 |
Terminated 3 on December 09, 2003 |
| Recall Number | Z-0012-04 |
|---|
| Recall Event ID |
26231 |
| 510(K)Number | K953239 |
|---|
| Product | Roche/Hitachi Modular Analytics P clinical chemistry analyzer; Modular P. Catalog number 766-8156. |
|---|
| Code Information |
All units with current software versions (v 06-06 and 07-01). |
| FEI Number |
1823260
|
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Road
Indianapolis IN 46250-0457
|
| For Additional Information Contact |
800-428-2336 |
|---|
Manufacturer Reason
for Recall | Incorrect results, without a data flag, reported if one of the other reagent containers becomes depleted before the R1 reagent is depleted. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Customers were notified by certified mail on or about May 12, 2003. Operators were given a workaround (assure R1 has the lower number of tests remaining before using the analyzer) until new software is supplied. |
|---|
| Quantity in Commerce | 478 |
|---|
| Distribution | United States |
|---|
|
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 =
|
|---|
