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U.S. Department of Health and Human Services

Class 2 Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph ID

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 Class 2 Device Recall Sure Vue Color Staph IDSure Vue SELECT Staph IDbiokit Color Staph IDbiokit SELECT Staph IDsee related information
Date Initiated by FirmFebruary 19, 2016
Date PostedJune 03, 2016
Recall Status1 Terminated 3 on February 28, 2017
Recall NumberZ-1911-2016
Recall Event ID 74140
Product Classification Staphylococcus aureus protein a insoluble - Product Code LHJ
ProductSure Vue Color Staph 150T, Sure Vue Color Staph 300T, Sure Vue SELECT Staph, biokit SELECT Staph 75T The product is used as an aid in the identification of Staphylococcus aureus from Culture
Code Information Lot Numbers - KJ05016, KJ05017, KJ05018, KJ06019, KJ06020, KJ06021, KJ07023, KJ10028, J06022, KJ07024, KJ07025, KJ09026, KJ09027, KJ10029, KJ10030, KJ11034, KJ11035, KJ12040, KJ12041, KJ12042, KJ12043
Recalling Firm/
Manufacturer		 Integrated Science Systems Inc
1215 George C Wilson Dr Unit A4
Augusta GA 30909-5700
For Additional Information ContactTeena S.Enriquez
706-922-8686
Manufacturer Reason
for Recall		Customer complaints of very weak reactions with the kit, or false negative results with different Staph aureus cultures.
FDA Determined
Cause 2		Process control
ActionIntegrated Science Systems sent a Recall Notification letter dated March 29, 2016. Integrated Science Systems requested that unopened kits in inventory be returned. Once the root cause has been determined, the kits will be reworked and returned to INOVA for distribution. For questions call 706-922-8686.
Quantity in Commerce2625 kits
DistributionNationwide distribution to CA only.
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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