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Nanosphere, Inc.

Complete recall history across all FDA and CPSC categories — 11 total recalls

Nanosphere, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (11)

FDA medical device enforcement actions by Nanosphere, Inc.

Date Product Reason Class
Jul 9, 2014 Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene ... Nanosphere Inc. has recently determined through four customer complaints that... Class II
Apr 17, 2014 Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed usi... Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 0... Class II
Mar 18, 2014 Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists... Nanosphere has recieved reports related to an unacceptable increase in initia... Class III
Oct 16, 2013 Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid... Nanosphere has received report of an increased rate of "No Call - INT CTL 2" ... Class III
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Proc... Class II
Oct 10, 2013 The Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN), performed... Nanosphere has received several reports relating to an increased rate of Proc... Class II
Oct 10, 2013 The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, ... Nanosphere has received several reports relating to an increased rate of Proc... Class II
Oct 10, 2013 The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene S... Nanosphere has received several reports relating to an increased rate of Proc... Class II
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Proc... Class II
Jun 17, 2013 Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Car... There is a specific Extraction Tray lot containing Tips that may slightly inc... Class II
Jun 17, 2013 Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Car... There is a specific Extraction Tray lot containing Tips that may slightly inc... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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