Recall Z-1051-2017 ยท PAM Gram-Positive Bacteria And Their Resistance Markers
Great Basin Scientific, Inc.
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 Staphylococ
| Date | Jan 19, 2017 (initiated Dec 12, 2016) |
| Status | Terminated |
| Reason | The Great Basin Staph ID/R Panel is being recalled because the S. aureus probe could potentially result in a false positive. |
| Root cause | 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 | 32 Kits (320 individual disposable cartridges) |
| Distribution | US Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152470 | Great Basin Staph ID/R Blood Culture Panel Great Basin Scientific, Inc., Mar 25, 2016 |