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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 Device
Medical Devices/Diagnostic Equipment

Becton Dickinson & Co.: BD BACTEC MGIT 960 PZA Kit Recalled for Potential False Test Results

Agency Publication Date: August 16, 2024
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Summary

Becton Dickinson & Co. is recalling approximately 12,383 units of the BD BACTEC MGIT 960 PZA Kit, which is used in laboratories to test the susceptibility of tuberculosis bacteria to the drug pyrazinamide (PZA). The kits may intermittently produce false results indicating the bacteria is resistant to the drug when it is actually sensitive. This defect could lead to patients receiving incorrect or unnecessary treatment for tuberculosis. These kits were distributed worldwide, including across the United States, and the firm has initiated a voluntary recall to address the diagnostic error.

Risk

If a test incorrectly shows that tuberculosis is resistant to pyrazinamide, a doctor might prescribe a more toxic or less effective alternative medication. This can lead to unnecessary side effects for the patient or a delay in effective treatment for a serious infection.

What You Should Do

  1. Check your laboratory inventory for the BD BACTEC MGIT 960 PZA Kit with Catalog Number 245128 and UDI-DI (01) 0038290245128.
  2. Verify if your kit matches one of the following affected lot numbers: 3104416, 3156654, 3191569, 3233971, 3241654, 3248314, 3269157, 3298311, 3298317, 3304389, 3324422, 3338965, 4002353, 4009894, 4036330, or 4051247.
  3. Contact your healthcare provider or Becton Dickinson & Co. for specific instructions regarding the continued use of these test kits and to discuss potential impact on previous test results.
  4. Contact Becton Dickinson & Co. at their Sparks, Maryland location or through their official website to determine if a refund or replacement is available for the affected lots.
  5. For further questions or to report issues, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: BD BACTEC MGIT 960 PZA Kit
Model / REF:
245128
UPC Codes:
0038290245128
Lot Numbers:
3104416
3156654
3191569
3233971
3241654
3248314
3269157
3298311
3298317
3304389
3324422
3338965
4002353
4009894
4036330
4051247

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95023
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Becton Dickinson & Co. direct distribution
Manufactured In: United States
Units Affected: 12,383 eaches
Distributed To: Nationwide

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

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.