Class I — Nova Biomedical Corporation
| Recalling firm | NOVA BIOMEDICAL CORP. |
|---|---|
| Registered facility | View this company's 4 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Terminated |
| Reason | Reports of false abnormally high glucose readings from test strips |
| Product | Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to be used for the quantitative measurement of glucose in fresh capillary whole blood. They are intended for use by people with diabetes mellitus in the home and by healthcare professionals in clinical settings as an aid to monitor the effectiveness of diabetes control |
| Quantity | 721,810 test strips |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua |
| Initiated | 2013-07-15 |
| Classified | 2013-08-09 |
| Terminated | 2017-08-01 |
| Recall number | Z-1899-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — Nova Biomedical Corporation (Z-1899-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/65617/
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