Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported August 21, 2013
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 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 t
Reports of false abnormally high glucose readings from test strips
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Nova Biomedical Corporation recalled Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: … - a critical-severity action.
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: … was recalled by Nova Biomedical Corporation in August 21, 2013. Reason: Reports of false abnormally high glucose readings from test strips. Check the official notice for the remedy. Verify recall #Z-1897-2013 with the FDA Devices before acting.
The recall
Nova Biomedical Corporation issued this critical-severity FDA Devices recall-Reports of false abnormally high glucose readings from test strips.
- Critical
- severity level
- Class I
- classification
- August 21, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1897-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1897-2013) was formally reported on August 21, 2013, with the manufacturer initiating the action on July 15, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Nova Biomedical Corporation is listed as the recalling firm, operating out of Waltham, MA. Federal records list the affected scope as 22,395,802 test strips.
The documented reason for this recall is: Reports of false abnormally high glucose readings from test strips Distribution data in the federal record shows the product reached: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
22,395,802 test strips
Related Recalls
6
3 from same agency
Product description
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1897-2013 |
| Date reported | August 21, 2013 |
| Date initiated | July 15, 2013 |
| Recalling firm | Nova Biomedical Corporation |
| Firm location | Waltham, MA |
| Affected scope | 22,395,802 test strips |
| Distribution | Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1897-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 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. Recalled by Nova Biomedical Corporation. Units affected: 22,395,802 test strips.
Why was this product recalled? ▼
Reports of false abnormally high glucose readings from test strips
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2013. Severity: Critical. Recall number: Z-1897-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1897-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.