PlainRecalls

Nanosphere, Inc.

Compiled from official public sources by the publisher.

11 recalls on record · Latest: Oct 8, 2014

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Agency notice ledger

Federal filing book Nanosphere, Inc. LIGHT-BOOK · SINGLE-AGENCY

#1,372 of 14,151 · 11 notices · 0.011% archive

  • BOOK 11 notices
  • RANK #1,372 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (11)
  • CAT medical devices
  • CATS 1 category
  • LATEST Oct 8, 2014
  • PHOTO Agfa Corp.

Nearest notice-volume peer: Agfa Corp. (0 notice gap)

Nanosphere, Inc. accounts for about 0.011% of the 104,423-notice archive on 11 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

Where Nanosphere, Inc. sits among 14,151 recalling firms

Nanosphere, Inc. ranks 1,372nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Nanosphere, Inc. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

11 1372nd of 14151 higher than 12,735 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Nanosphere, Inc. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Nanosphere, Inc. holds about 0.011% of archive notices alongside 11 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Oct 8, 2014

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.
FDA Devices Moderate Oct 8, 2014

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.
FDA Devices Moderate Oct 1, 2014

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 individuals with signs and symptoms of gastrointestinal infection. The test is performed on the automated Nanosphere Verigene System utilizing reverse transcription (RT), polymerase chain reaction (PCR), and array hybridizati
FDA Devices Moderate Oct 1, 2014

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 signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncyti
FDA Devices Moderate Oct 1, 2014

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 PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is
FDA Devices Moderate Oct 1, 2014

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 blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram negative bacteria as determined by gram st
FDA Devices Moderate Oct 1, 2014

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 may cause bloodstream infection (BSI). BC-UP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria. BC-UP detects a
FDA Devices Low Sep 3, 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.
FDA Devices Moderate Aug 20, 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 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.
FDA Devices Low Aug 20, 2014

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 sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patient
FDA Devices Moderate Aug 20, 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 culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain.

Nanosphere, Inc. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (11 here — thin-book).

Agfa Corp. 11 Ajinomoto Foods North America Inc. 11 Akron Pharma, Inc. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Agfa Corp. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11 Arjohuntleigh Polska Sp. z.o.o. 11

Frequently Asked Questions

How many federal recall notices name Nanosphere, Inc.? ▼
PlainRecalls indexes 11 distinct federal recall events naming Nanosphere, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Nanosphere, Inc. sit among other recalling firms? ▼
Nanosphere, Inc. ranks #1,372 of 14,151 by distinct recall-event count among 14,151 firms in this archive (90th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Nanosphere, Inc.'s notices? ▼
FDA Devices accounts for 11 of this firm's 11 indexed notices.
What product category dominates Nanosphere, Inc.'s filing book? ▼
Filings for Nanosphere, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Nanosphere, Inc.: 11 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Nanosphere, Inc.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026