Recall Z-2236-2014
Nanosphere, Inc. · initiated July 9, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
Nanosphere sent an Urgent Product Recall letter dated July 9, 2014 to all affected customers. All customers were initially notified of the recall by telephone on July 9, 2014. The customers were instructed to quarantine and return all affected product to Nanosphere. The letter included instructions: 1) on how to return the recalled products, and 2) to review any test results that were generated while using the recalled products to ensure that there has been no negative impact on patient care. Customers with questions were instructed to contact Nanosphere at 888-837-4436, option 2 or via e-mail at Technicalsupport@nanosphere.us.
Details
- Recall number
- Z-2236-2014
- Initiated
- July 9, 2014
- Posted by FDA
- August 14, 2014
- Terminated
- September 1, 2015
- Product code
- PEN – Gram-Negative Bacteria And Associated Resistance Markers
- Quantity
- 1045 extraction trays (840 affected by recall)
- Distribution
- Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
- Recalling firm
- Nanosphere, Inc., Northbrook, IL