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U.S. Department of Health and Human Services

Class 2 Device Recall Strep A Test Card

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 Class 2 Device Recall Strep A Test Cardsee related information
Date Initiated by FirmMarch 04, 2014
Date PostedApril 07, 2014
Recall Status1 Terminated 3 on May 09, 2014
Recall NumberZ-1349-2014
Recall Event ID 67665
ProductStrep A Test Card; LumiQuick, Santa Clara, CA 95054
Code Information Catalog number: 71048, All lots
Recalling Firm/
Manufacturer
LumiQuick Diagnostics Inc.
2946 Scott Blvd
Santa Clara CA 95054-3312
For Additional Information ContactDoug Rundle
408-855-0061
Manufacturer Reason
for Recall
Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) clearance.
FDA Determined
Cause 2
No Marketing Application
ActionUrgent Device Recall notification letters were sent to all US consignees on March 4, 2014 by e-mail and US mail as well as a phone call. The letter identified the products and actions to be taken by the customers.
Quantity in CommerceALL
DistributionDistributed in the states of CA, FL, NJ, TX, and NY.

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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