Nanosphere, Inc.

FDA recalling firm · 6 enforcement events · 11 product records · 2013–2014 · IL

Nanosphere, Inc. has 6 FDA enforcement events on this register (11 product records) between 2013 and 2014: 6 device; the busiest year was 2013 with 3.

0% of its events are Class I; the most common class is Class II (4). 0 events are listed as ongoing; the recalling firm's address is in IL.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
9 Jul 2014	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…	Device	Class II	1	Terminated
17 Apr 2014	Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood…	Device	Class II	1	Terminated
18 Mar 2014	Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.	Device	Class III	1	Terminated
16 Oct 2013	Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit. The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene…	Device	Class III	1	Terminated
10 Oct 2013	The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on…	Device	Class II	5	Terminated
17 Jun 2013	Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.	Device	Class II	2	Terminated

By type and class

Device6

Class II4

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Nanosphere, Inc. by year initiated.

Questions and answers

How many FDA recalls has Nanosphere, Inc. had?

6 enforcement events (11 product records) on this register, 2013–2014: 6 device.

Are any Nanosphere, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Nanosphere, Inc. recalls?

4 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.