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U.S. Department of Health and Human Services

Class 2 Device Recall Great Basin Staph lD/R Blood Culture Panel

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  Class 2 Device Recall Great Basin Staph lD/R Blood Culture Panel see related information
Date Initiated by Firm December 12, 2016
Date Posted January 19, 2017
Recall Status1 Terminated 3 on March 31, 2017
Recall Number Z-1051-2017
Recall Event ID 76076
510(K)Number K152470  
Product Classification Gram-positive bacteria and their resistance markers - Product Code PAM
Product Great Basin Staph lD/R Blood Culture Panel

The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.
Code Information Lot 1629103 Catalog Number: GBSIDR-10 Unique Device ldentifier (UDl): B1 78GBS|DR102
Recalling Firm/
Manufacturer		 Great Basin Scientific, Inc.
2441 S 3850 W
Salt Lake City UT 84120-7209
For Additional Information Contact Chuck Owen
801-990-1055
Manufacturer Reason
for Recall		 The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive.
FDA Determined
Cause 2		 Material/Component Contamination
Action The firm, Great Basin Scientific, notified customers by phone beginning on December 12, 2016 and by email on December 14 and 15, 2016. The notifications described the product, problem and actions to be taken. The customers were instructed to cease using and immediately discard all affected cartridges, the firm will replace those cartridges as soon as possible; and respond to the email or call Direct: 385.219.4540 or Support Team 888.333.9763 or email: customerssupport@gbscience.com with any questions or concerns.
Quantity in Commerce 32 Kits (320 individual disposable cartridges)
Distribution US Nationwide Distribution.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = PAM and Original Applicant = GREAT BASIN SCIENTIFIC, INC.
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