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U.S. Department of Health and Human Services

Class 1 Device Recall VITEK GPS107 Gram Positive Susceptibility Card

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 Class 1 Device Recall VITEK GPS107 Gram Positive Susceptibility Cardsee related information
Date Initiated by FirmJanuary 28, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on April 18, 2005
Recall NumberZ-0721-04
Recall Event ID 28431
Product Classification System, Test, Automated, Antimicrobial Susceptibility, Short Incubation - Product Code LON
ProductVITEK 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 #M83X, Exp. 4/15/05
Recalling Firm/
Manufacturer
bioMerieux Inc
595 Anglum Rd
Hazelwood MO 63042-2320
For Additional Information ContactNancy Weaver
314-731-8595
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
ActionThe firm issued recall letters dated 1/28/04 via regular mail requesting remaining inventories be destroyed and explaining the method which the customer can use to confirm the cards were not misreported. A 'Second Notification' recall letter was issued dated 3/9/04.
Quantity in Commerce1,988/20-card boxes
DistributionDistribution was made nationwide to medical facilities, which includes military and government consignees. Distribution was also made to foreign consignees located in Colombia, Costa Rica, and China.
Total Product Life CycleTPLC 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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