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.

Recall Insight

This FDA Devices action (record #Z-2236-2014) was formally reported on August 20, 2014, with the manufacturer initiating the action on July 9, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Nanosphere, Inc. is listed as the recalling firm, operating out of Northbrook, IL. Federal records list the affected scope as 1045 extraction trays (840 affected by recall).

The documented reason for this recall is: 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 mi… Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.