| Class 1 Device Recall VITEK GPS107 Gram Positive Susceptibility Card | |
Date Initiated by Firm | April 20, 2004 |
Date Posted | July 20, 2004 |
Recall Status1 |
Terminated 3 on April 18, 2005 |
Recall Number | Z-0917-04 |
Recall Event ID |
28871 |
Product Classification |
System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
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Product | VITEK GPS-107Gram Positive Susceptibility Card, Catalog #V4368, for in-vitro diagnostic use, 20 cards per package. The responsible firm on the label is bioMerieux, Inc., Durham, NC. |
Code Information |
Lot #B28E |
Recalling Firm/ Manufacturer |
bioMerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
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For Additional Information Contact | Nancy Weaver 314-731-8695 |
Manufacturer Reason for Recall | Some of the cards were stamped with an incorrect card code causing the system to read and report the cards incorrectly. |
FDA Determined Cause 2 | Other |
Action | The firm issued recall letters dated 4/20/04 via certified mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. |
Quantity in Commerce | 1,990/20-card boxes |
Distribution | Distribution was made to medical centers and laboratories nationwide, which include government and military consignees. Foreign distribution was made to bioMerieux subsidiaries in Switzerland, Portugal, and the Philippines. |
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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