| Date Initiated by Firm | September 29, 2006 |
|---|
| Date Posted | November 29, 2006 |
|---|
| Recall Status1 |
Terminated 3 on March 13, 2007 |
| Recall Number | Z-0222-2007 |
|---|
| Recall Event ID |
36699 |
| 510(K)Number | K982238 |
|---|
| Product Classification |
In Vitro Diagnostic - Product Code MJH
|
| Product | NOW Legionella Urinary Antigen Test. 22 test kit. For In Vitro Diagnostic Use
Product Code: 852-000 |
|---|
| Code Information |
Lot Number: 024448 Exp. Date: March 14, 2008 |
Recalling Firm/
Manufacturer |
Inverness Medical Professional Diagnostics
10 Southgate Rd
Scarborough ME 04074-8303
|
| For Additional Information Contact | Jenny Fuchs
207-730-5740 |
|---|
Manufacturer Reason
for Recall | Mislabeled product: Outer kit label reads NOW Legionella Urinary Antigen Test, inside contains S. pneumonia test pouches |
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FDA Determined
Cause 2 | Other |
|---|
| Action | Binax Inc. DBA Inverness Medical notified consignees by letter on 09/29/06 advising users to return unused product and distributors to recall to the user level. |
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| Quantity in Commerce | 531 kits |
|---|
| Distribution | Worldwide, including USA, Canada, EU, South Korea, Singapore |
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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.
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| 510(K) Database | 510(K)s with Product Code = MJH
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