FDA Device recall Z-1905-2013
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for us…
- FDA Device
- Class I
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class I recall of Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 Product usage: The Nova Max Glucose Test Strips are for us… by Nova Biomedical, citing reports of false abnormally high glucose readings from test strips.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1905-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-07-15 |
| Published | 2013-08-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Nova Biomedical |
| Distribution | US |
Product
Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861 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
Reason
Reports of false abnormally high glucose readings from test strips
Identifiers
| code_info | 1010112073 10/31/2013 1010113002 03/31/2014 1010113008 03/31/2014 1010312097* 10/31/2013 1010512080** 10/31/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1905-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.