Manufacturer

Nanosphere, Inc.

11 recalls in our database name Nanosphere, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 1
Most recent: 2014-10-08

Of the 11 recalls from Nanosphere, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (9%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

ModerateFDA (Devices)·Z-2735-2014·2014-10-08
Nanosphere Verigene BC-GP Kit Extraction Tray Recall
Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2736-2014·2014-10-08
Nanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk
Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.
Product
Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN 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.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2685-2014·2014-10-01
Nanosphere Verigene Enteric Pathogens Test Recalled for Processing Errors
Nanosphere is recalling 220 units of the Verigene Enteric Pathogens Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.
Product
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simultaneous detection and identification of common pathogenic enteric bacteria and genetic virulence markers from liquid or soft stool preserved in Cary-Blair media, collected from indiv
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2682-2014·2014-10-01
Nanosphere Recalls Verigene Clostridium difficile Test Due to Processing Errors
Nanosphere is recalling 80 units of the Verigene Clostridium difficile Nucleic Acid Test due to increased processing errors caused by Tip Holder Assemblies.
Product
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 sequences of toxigenic strains Clostridium difficile and for presumptive identification of PC
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2681-2014·2014-10-01
Nanosphere Recalls Verigene Gram Negative Blood Culture Test Kits
Nanosphere is recalling 400 units of the Verigene Gram Negative Blood Culture Nucleic Acid Test due to an increased rate of processing errors caused by tip holder assemblies.
Product
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 mark
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2684-2014·2014-10-01
Nanosphere Recalls Verigene Respiratory Virus Plus Test Due to Processing Errors
Nanosphere is recalling Verigene Respiratory Virus Plus tests because Tip Holder Assemblies caused increased processing errors on the Processor SP.
Product
The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with sign
Category
Medical Device
Distribution
25 states
ModerateFDA (Devices)·Z-2683-2014·2014-10-01
Nanosphere Recalls Verigene Gram-Positive Blood Culture Test Due to Processing Errors
Nanosphere is recalling 4,440 units of the Verigene Gram-Positive Blood Culture Nucleic Acid Test because Tip Holder Assemblies caused increased processing errors.
Product
The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which
Category
Medical Device
Distribution
25 states
LowFDA (Devices)·Z-2559-2014·2014-09-03
Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits
Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.
Product
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.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-2168-2014·2014-08-20
Nanosphere Recalls Verigene CDF Amplification Trays Due to Increased Error Rates
Nanosphere is recalling specific lots of Verigene CDF Amplification Trays because they produced an increased rate of 'No Call - INT CTL 2' results when testing negative samples.
Product
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 tox
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-2236-2014·2014-08-20
Nanosphere Recalls Verigene BC-GN Test Kits Due to Missing Particles
Nanosphere is recalling Verigene BC-GN Test Kits because some extraction trays are missing magnetic microparticles required for DNA extraction.
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 ge
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2170-2014·2014-08-20
Nanosphere Recalls Verigene Gram-Negative Blood Culture Test Cartridges
Nanosphere is voluntarily recalling Verigene Gram-Negative Blood Culture Test Cartridges due to an elevated risk of No Call and False Negative results.
Product
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.
Category
Medical Device
Distribution
10 states