| Date Initiated by Firm | February 14, 2006 |
|---|
| Date Posted | April 22, 2006 |
|---|
| Recall Status1 |
Terminated 3 on March 06, 2008 |
| Recall Number | Z-0786-06 |
|---|
| Recall Event ID |
34612 |
| 510(K)Number | K883540 |
|---|
| Product Classification |
System, Test, Infectious Mononucleosis - Product Code KTN
|
| Product | Oxoid Infectious Mononucleosis Test, Catalog #DR0680M. The firm name on the label is Oxoid, Ltd., Basingstoke, Hants, England |
|---|
| Code Information |
Lot 382735, Exp. 2006/06/30 |
Recalling Firm/
Manufacturer |
Remel, Inc.
12076 Santa Fe Trail Dr
(PO Box 14478, zip 66285-4478)
Lenexa KS 66215-3519
|
| For Additional Information Contact | Robert Booth
913-895-4007 |
|---|
Manufacturer Reason
for Recall | Some units exhibit weak false-positive reactions with some negative patient serum |
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FDA Determined
Cause 2 | Other |
|---|
| Action | The recalling firm issued a letter dated 2/14/06 to their only customer requesting the product be destroyed.
The distributor was audited by FDA to assure subrecall |
|---|
| Quantity in Commerce | 27 units |
|---|
| Distribution | Nationwide-Distribution was made to a New Jersey distributor. |
|---|
| 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.
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| 510(K) Database | 510(K)s with Product Code = KTN
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