Device product
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
Z-2736-2014
Product summary
- Firm
- Nanosphere, Inc.
- Event
- Event 68014
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 extraction trays
- Official record key
device-enforcement:Z-2736-2014
Official wording
Reason: There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.
Code information: Part Number: 20-009-021; Lot Numbers: 052113021C
Distribution pattern: Worldwide Distribution:US (Nationwide) including states of: AZ, CA, FL, IL, KY, MD, MN, MT, OH, PA, TN, TX, VA, WA, WI; and countries of: Belgium, China, and Saudi Arabia.
Derived failure modes
-
Unknown
There is a specific Extraction Tray lot containing Tips that may slightly increase the occurrence of Process SP Processing Error when used due to the Processor SP experiencing difficulty releasing the Tip to the final location in the Tip Assembly. The difficult releasing the Tip can result in a Processing Error and occasionally the Tip to be dropped into the Processor SP.