Recall record at a glance
| Official record | Z-1903-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Nova Biomedical Corporation |
| Report date | Aug 21, 2013 |
| Recall initiation date | Jul 15, 2013 |
| Quantity | 1,316,420 kits |
| Location | Waltham, MA, United States |
Official product description
Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 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
Why the product was recalled
Reports of false abnormally high glucose readings from test strips
Distribution information
Worldwide Distribution - USA Nationwide and the countries of Chile, England , Peru, Nicaragua
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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