Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Enforcement
- Recall Number
- Z-2236-2014
- Event ID
- 68831
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Nanosphere, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- August 20, 2014
- Initiation Date
- July 9, 2014
- Classification Date
- August 14, 2014
- Termination Date
- September 1, 2015
- Address
- 4088 Commercial Ave, N/A, Northbrook, IL, 60062-1829, United States
Description
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
1045 extraction trays (840 affected by recall)