| Date Initiated by Firm | March 14, 2008 |
|---|
| Date Posted | May 13, 2009 |
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| Recall Status1 |
Terminated 3 on May 16, 2012 |
| Recall Number | Z-1327-2009 |
|---|
| Recall Event ID |
47475 |
| 510(K)Number | K961587 |
|---|
| Product Classification |
Ferrozine Iron Binding Capacity - Product Code JMO
|
| Product | Diagnostics Chemical Limited Iron Assay
Catalog Number: 102-25
For the In Vitro quantitative determination of iron in serum. |
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| Code Information |
Lot Number: 33361 Exp: October 2010 |
Recalling Firm/
Manufacturer |
Diagnostic Chemicals, Ltd.
16 McCarville Street
Charlottetown Canada Prince Edward Island
|
Manufacturer Reason
for Recall | Precipitate in product may cause elevated background absorbance interference. |
|---|
FDA Determined
Cause 2 | Process control |
|---|
| Action | Genzyme Diagnostics P.E.I. Inc. notified the 1 account by a Removal Notification letter on 3/14/08 requesting that they stop using and discard any remaining stock. The customer is to request replacement through their normal channels. Questions or concerns should be directed to Penny White of Genzyme. |
|---|
| Quantity in Commerce | 153 kits |
|---|
| Distribution | Nationwide Distribution |
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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 = JMO
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