The Recall Desk
SevereFDA (Devices)·Z-0650-2014·Announced 2014-01-15

Nova Hospital Blood Glucose Meters Recalled for Battery Swelling and Leakage

Nova Biomedical is recalling hospital blood glucose meters due to battery swelling and cell leakage. The recall covers approximately 200,000 units distributed nationwide.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant injury or property damage (such as battery leakage/swelling) are classified as Severe (Score 4).

Plain-English summary

Nova Biomedical Corporation is recalling approximately 200,000 units of the Nova StatStrip/StatSensor Hospital Blood Glucose Meter, Nova StatStrip Lactate Hospital Meter System, and Nova StatSensor Creatinine Hospital Meter. The recall is being conducted because the rechargeable lithium batteries in these devices may swell and leak cells. The affected products are intended for point-of-care usage in the quantitative determination of glucose in whole blood.

The recalled products were distributed nationwide. The recall includes all serial numbers for the specific battery configurations: Single (46626), 4 Pack (46827), and 5 Pack (50436). The source text does not specify a date range for the distribution or the specific dates of manufacture.

Consumers and healthcare facilities should stop using the affected meters and contact Nova Biomedical Corporation for instructions on removal and expiration dates. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Nova StatStrip/StatSensor Hospital Blood Glucose Meter; Nova StatStrip Lactate Hospital Meter System; Nova StatSensor Creatinine Hospital Meter, Rechargeable Lithium Batteries Single: 46626; 4 Pack: 46827; 5 Pack: 50436. For Point-Of-Care usage in the quantitative determin
Manufacturer
Nova Biomedical Corporation
Category
Medical Device — Blood Glucose Meter
Hazard
Affected units
200,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All serial numbers

Distribution

Distributed nationwide across the United States.

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Same hazard · battery swelling

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