| Date Initiated by Firm | April 18, 2005 |
|---|
| Date Posted | June 04, 2005 |
|---|
| Recall Status1 |
Terminated 3 on October 13, 2005 |
| Recall Number | Z-0866-05 |
|---|
| Recall Event ID |
31942 |
| 510(K)Number | K042476 |
|---|
| Product Classification |
Enzyme Immunoassay, Valproic Acid - Product Code LEG
|
| Product | VITROS VALP Reagent , REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Responsible firm on the label: Ortho-Clinical Diagnostics, Inc., Rochester, N.Y. 14626. |
|---|
| Code Information |
01-5871, Exp. 31Jan06 |
| FEI Number |
1000136573
|
Recalling Firm/
Manufacturer |
Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester NY 14626-5101
|
| For Additional Information Contact | Judy M. Strzepek
908-218-8524 |
|---|
Manufacturer Reason
for Recall | Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days. |
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FDA Determined
Cause 2 | Other |
|---|
| Action | Letters dated 4/18/2005 with instructions to process a mid-level QC fluid every eight hours when processing patient samples for valproic acid. Replacement product to be shipped as soon as available. |
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| Quantity in Commerce | 139 boxes |
|---|
| Distribution | 37 U.S. consignees nationwide.
Ortho-Clinical foreign affiliates in England, France and Spain. |
|---|
| 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
|
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