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.
This recall has been terminated (originally issued September 30, 2014).
- Company
- Nanosphere, Inc.
- Recall Initiated
- June 17, 2013
- Posted
- September 30, 2014
- Terminated
- March 14, 2016
- Recall Number
- Z-2735-2014
- Quantity
- 1,660 extraction trays
- Firm Location
- Northbrook, IL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
Part Number: 20-009-018; Lot Numbers: 051713018B, 052413018C
Root Cause
Process change control
Action Taken
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.