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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Vet
Pets & Animals/Pet Medications

Nova Biomedical Prime Plus Vet Analyzers Recalled for Inaccurate Results

Agency Publication Date: November 15, 2023
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Summary

Nova Biomedical Corporation has recalled 215 units of the Prime Plus Vet Analyzer and remanufactured models because they may report incorrect creatinine levels. This issue typically occurs within the first 2 to 4 hours after a new sensor cartridge is installed and may not be detected by standard quality control checks. The recall affects several software versions used by veterinary professionals for animal blood testing.

Risk

The device may provide erroneous creatinine results during the initial start-up of a new sensor cartridge. Inaccurate test results could lead to improper diagnosis or incorrect treatment decisions for animals under veterinary care.

What You Should Do

  1. Identify if your analyzer is affected by checking the serial number and software version (V1.17.1129.0, V3.2.1129.0, or V1.50.1129.0) on your device. See the Affected Products section below for the full list of affected codes.
  2. Stop using the recalled product.
  3. Contact Nova Biomedical or your distributor to arrange for a return, replacement, or correction of the device.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return or proper disposal.

Affected Products

Product: Nova Biomedical Prime Plus Vet Analyzer
Variants: Remanufactured Model 59422, Software Release V1.17.1129.0, Software Release V3.2.1129.0, Software Release V1.50.1129.0
Model:
57808
59422
Serial Numbers (205):
PP2118040C
PP2118060C
PP2119010C
PP2119020C
PP2119070C
PP2120020C
PP21220030C
PP21220070C
PP21220090C
PP2218040C
PP2218070C
PP2218140C
PP22220010C
PP22230020C
PP22230040C
PP22230060C
PP22230090C
PP22230110C
PP2318020C
PP2318030C
PP23230010C
PP23230020C
PP23230030C
PP23230040C
PP2418040C
PP2419010C
PP2419020C
PP2419030C
PP2519020C
PP2519030C
PP2619010C
PP2619030C
PP2619060C
PP26200010C
PP26200030C
PP26220020C
PP26220040C
PP26220090C
PP2718020C
PP2718050C
PP2719050C
PP2719060C
PP2719070C
PP2719080C
PP2719090C
PP2719100C
PP2719110C
PP2719120C
PP2719130C
PP2719140C

Units affected include US and OUS (Outside US) serial numbers. Indicated for quantitative determination of multiple blood parameters including Creatinine and BUN.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93397
Status: Active
Manufacturer: Nova Biomedical Corporation
Sold By: Veterinary healthcare distributors; Direct sales
Manufactured In: United States
Units Affected: 215 units
Distributed To: Nationwide
Agency Last Updated: November 28, 2023

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response