Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in
FDA device recall Z-1051-2017 · posted 2017-01-19 · Terminated
Recall details
- Recalling firm
- Great Basin Scientific, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- PAM
- Quantity affected
- 32 Kits (320 individual disposable cartridges)
- Distribution
- US Nationwide Distribution.
- Date initiated
- 2016-12-12
- Date posted
- 2017-01-19
- Date terminated
- 2017-03-31
- Location
- Salt Lake City, UT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 |