| Date Initiated by Firm | August 10, 2004 |
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| Date Posted | July 24, 2007 |
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| Recall Status1 |
Terminated 3 on November 27, 2007 |
| Recall Number | Z-1103-2007 |
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| Recall Event ID |
38313 |
| 510(K)Number | K933588 |
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| Product Classification |
in vitro diagnostic - Product Code MID
|
| Product | american diagnostica inc. IgM Conjugate, 15mL; component of the american diagnostica, inc. IMUCLONE aPL IgM ELISA Kit, Product #649M; manufactured by Louisville APL Diagnostics, Inc., Seabrook, TX 77586. |
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| Code Information |
Lot #040531. |
Recalling Firm/
Manufacturer |
Louisville Apl Diagnostics Inc
2622 NASA Parkway, Suite G2
Seabrook TX 77586-3447
|
| For Additional Information Contact |
770-455-7129 |
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Manufacturer Reason
for Recall | Product mislabeled; conjugate IgG placed in bottles labeled as conjugate IgM and vice versa. |
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FDA Determined
Cause 2 | Other |
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| Action | Firm notified consignee of recall via phone on 08/10/04. Consignee asked to return conjugates for properly labeled replacements. |
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| Quantity in Commerce | 35 IgM kits. |
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| Distribution | Product distributed to a single direct account in CT. |
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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 = MID
|
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