Verigene BC-GN Test Kit — Class II medical device recall Z-2236-2014

Terminated recall by Nanosphere, Inc., reported 2014-08-20, distributed nationwide. Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-

Recall number	`Z-2236-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Nanosphere, Inc., Northbrook, IL, United States
Recall initiated	2014-07-09
Classified	2014-08-14
Reported by FDA	2014-08-20
Terminated	2015-09-01
Distributed	Nationwide (US)
Lot numbers	`042914021B`
Model numbers	`20-005-021`, `20-006-021`
Expiration dates	`2014-10-26`

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.

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2236-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.