| Date Initiated by Firm | September 06, 2006 |
|---|
| Date Posted | February 27, 2007 |
|---|
| Recall Status1 |
Terminated 3 on May 14, 2007 |
| Recall Number | Z-0536-2007 |
|---|
| Recall Event ID |
36864 |
| 510(K)Number | K042243 |
|---|
| Product Classification |
in vitro diagnostic - Product Code JIX
|
| Product | Microalbumin Multi-Calibrator Set, in vitro diagnostic.
Catalog Number: SE-252 |
|---|
| Code Information |
Lot Number: 28423 |
Recalling Firm/
Manufacturer |
Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
|
| For Additional Information Contact | Karen McIntyre
293-881-2020 |
|---|
Manufacturer Reason
for Recall | Microalbumin Multi Calibrator mislabeled label on Level 5 and Level 6, cap label correct |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | Diagnostic Chemicals Ltd, Canada notified customers by telephone and fax on 9/06/06 and advised to use the cap label to determine concentration of the calibrators. Accounts were asked to confirm and acknowledge receipt of the letter. |
|---|
| Quantity in Commerce | 38 kits |
|---|
| Distribution | Nationwide. |
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| 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 = JIX
|
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