Nova Max Glucose Test Strips — Class I medical device recall Z-1902-2013
Terminated recall by Nova Biomedical Corporation, reported 2013-08-21, distributed nationwide. Reports of false abnormally high glucose readings from test strips
| Recall number | Z-1902-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Nova Biomedical Corporation, Waltham, MA, United States |
| Recall initiated | 2013-07-15 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2017-08-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, GB, NI, PE |
| Quantity | 366,140 test |
| Lot numbers | 1020112086, 1020212032, 1020213074, 1020213109 |
| Model numbers | 45512 |
Product
Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 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 for recall
Reports of false abnormally high glucose readings from test strips
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1902-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.