| Date Initiated by Firm | December 23, 2004 |
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| Date Posted | February 15, 2005 |
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| Recall Status1 |
Terminated 3 on May 03, 2012 |
| Recall Number | Z-0541-05 |
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| Recall Event ID |
31078 |
| 510(K)Number | K970149 |
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| Product Classification |
Reagents, Antibody, Legionella, Direct & Indirect Fluorescent - Product Code LHL
|
| Product | The Is-Legionella IgG/IgM/IgA test kits are packaged in cardboard boxes with individual components secured within a foam insert. |
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| Code Information |
Lot # 91803Z and 30804/30804Z |
Recalling Firm/
Manufacturer |
Diamedix Corporation
2140 N Miami Ave
Miami FL 33127-4916
|
Manufacturer Reason
for Recall | The kits belonging to lot #s 30804/30804Z and 91803Z may lose activity, after one or two usages, causing the OD values for the Cut-Off Calibrator and/or Positive Control to be recovered below their specified ranges. |
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FDA Determined
Cause 2 | Other |
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| Action | Direct customers were notified by letter on 12/23/2004 by Federal Express.100% of the total customers will be contacted. The letter instructed the consignees to discontinue use immediately and arrange to return the product to Diamedix. |
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| Quantity in Commerce | 178 |
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| Distribution | Distributed to Domestic customers only. |
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| Total Product Life Cycle | TPLC Device Report |
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|
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 = LHL
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