FDA Medical Device Recalls (openFDA)
Nanosphere, Inc.: Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.
- Recall number
- Z-2735-2014
- Recalling firm
- Nanosphere, Inc.
- Product
- Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP 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.
- Status
- Terminated
- Initiated
- 2013-06-17
- Posted
- 2014-09-30
- Terminated
- 2016-03-14
- 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.
- Root cause
- Process change control
- Action
- Undated recall notification letters were sent to all direct accounts (customers) June 17 - 19, 2013. The letters included instructions for customers to: 1) check their inventory for the recalled products; 2) set any recalled products aside for return; and, 3) contact Nanosphere to obtain replacement tip holders. Customers with questions about this recall can contact Nanosphere via e-mail at technicalsupport@nanosphere.us or by calling 888-837-4436.
- Quantity
- 1,660 extraction trays
- Distribution
- 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.
- Lot, serial or model codes
- Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C
- 510(k) numbers
- ["K122514"]
- PMA numbers
- not on file
- Product code
- PAM
- Firm FEI
- 3006028115
- Firm city
- Northbrook
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28