FDA Device recall Z-1901-2013
Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43…
- FDA Device
- Class I
- terminated
- Published 2013-08-21
On 2013-08-21 the FDA classified a Class I recall of Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43… 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-1901-2013 |
| 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 Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507 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 | Lot #/Exp.Date: 1020212032 02/28/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074…Lot #/Exp.Date: 1020212032 02/28/2014 1020212153 06/30/2014 1020212207 07/31/2014 1020212291 10/31/2014 1020213074 03/31/2015 1020213109 04/30/2015 1020412255 09/30/2014 1020412341 12/31/2014 1020512087 03/31/2014 1020811350 12/31/2013 102121304 02/28/2015 |
|---|
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-1901-2013%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.