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.
FDA Recall Z-1051-2017 · Posted 2017-01-19
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Recalling FirmGreat Basin Scientific, Inc.
Recall StatusTerminated
Product CodePAM
Date Initiated2016-12-12
Date Terminated2017-03-31
Product Quantity32 Kits (320 individual disposable cartridges)
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.
Firm 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: [email protected] with any questions or concerns.
Root Cause
Material/Component Contamination
Distribution Pattern
US Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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