Nova Biomedical Corporation

Complete recall history across all FDA and CPSC categories — 19 total recalls

Nova Biomedical Corporation 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 (19)

FDA medical device enforcement actions by Nova Biomedical Corporation

Date Product Reason Class
Nov 20, 2024 StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... A software bug within the meter firmware leads to transmission of erroneous g... Class I
Nov 20, 2024 StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... A software bug within the meter firmware leads to transmission of erroneous g... Class I
Nov 20, 2024 StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to tr... Class I
Sep 18, 2023 Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blo... Potential risk of reporting erroneous creatinine patient results associated w... Class II
Sep 18, 2023 Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain ga... Potential risk of reporting erroneous creatinine patient results associated w... Class II
Jun 19, 2017 Nova Biomedical Stat Profile Prime Analyzer as follows: PN 52855 Stat Profil... Software- scheduled A-QC analysis could initiate prior to a patient result b... Class II
Oct 10, 2013 Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactat... Revised Battery Instructions for Removal and Expiration Date due to battery ... Class II
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Prod... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Produ... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count DME) Catalog Number: 43523 Product... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 ... Reports of false abnormally high glucose readings from test strips Class I
Jul 15, 2013 Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 ... Reports of false abnormally high glucose readings from test strips Class I
Feb 25, 2013 Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 51493 ... Glucose test strips reports no result message when tested Class II
Feb 25, 2013 Nova StatStrip Xpress Glu-Test Strips (Glucose test strips) Catalog # 42214 Glucose test strips reports no result message when tested 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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