Z-2236-2014 Class II Terminated
FDA device recall Z-2236-2014 was initiated by Nanosphere, Inc. on July 9, 2014 and is designated Class II. Reason for recall: 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 l… The recall status is terminated (terminated September 1, 2015). Affected quantity: 1045 extraction trays (840 affected by recall).
Recall Details
- Product Type
- Devices
- Report Date
- August 20, 2014
- Initiation Date
- July 9, 2014
- Termination Date
- September 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1045 extraction trays (840 affected by recall)
Product 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.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Code Information
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