Date Initiated by Firm | June 22, 2001 |
Date Posted | August 21, 2003 |
Recall Status1 |
Terminated 3 on August 20, 2003 |
Recall Number | Z-1147-03 |
Recall Event ID |
26578 |
510(K)Number | K984173 |
Product Classification |
System, Test, Anticardiolipin Immunological - Product Code MID
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Product | Anti-Cardiolipin IgA ELISA test kit. Product is manufactured by Zeus Scientific, Branchburg, NJ for Sigma Diagnostics, Inc., Saint Louis, MO. |
Code Information |
Sigma Product number 552-B; Lot Number 060K6464 Expiration Date: 12-05-2001 |
Recalling Firm/ Manufacturer |
Zeus Scientific Inc 200 Evans Way Branchburg NJ 08876
|
For Additional Information Contact | Mr. Mark Kopnitsky 908-526-3744 |
Manufacturer Reason for Recall | Bacterial contamination of the high positive control. |
FDA Determined Cause 2 | Other |
Action | Recall letter were sent via DHL to consignee on 6/22/2001 which instructed to return or discard any remaining inventory. |
Quantity in Commerce | 130 |
Distribution | All product was shipped to St. Louis, MO |
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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