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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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Low RiskFDA Device
Medical Devices/Diagnostic Equipment

BD BBL TB Stain Kit K Recalled for Incorrect Expiration Date

Agency Publication Date: March 6, 2025
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Summary

Becton Dickinson & Co. is recalling 247 units of the BD BBL TB Stain Kit K because one component in the kit was shipped with an incorrect expiration date printed on the label. While the component's label shows an expiration date of September 30, 2024, the official Certificate of Analysis (COA) confirms the component actually remains valid until April 30, 2025. No incidents or injuries have been reported in connection with this labeling error.

Risk

The labeling error may cause lab technicians to prematurely discard valid testing components or lead to confusion regarding the stability of the diagnostic kit. Because the components are still chemically viable until the correct expiration date in 2025, there is no direct risk of patient harm from degraded reagents.

What You Should Do

  1. The recalled product is the BD BBL TB Stain Kit K, catalog (REF) number 212522, lot number 4191205, and UDI-DI 00382902125228.
  2. Identify affected kits by checking the lot number 4191205 printed on the outer packaging and kit components.
  3. Stop using the recalled product. Contact Becton Dickinson & Co. or your medical distributor to arrange for a return, replacement, or label correction.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

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

Affected Products

Product: BD BBL TB Stain Kit K
Model / REF:
212522
Lot Numbers:
4191205 (Exp 2025/04/30)
UDI:
00382902125228
Date Ranges: Manufactured 07/10/2024

One kit component incorrectly labeled with expiration date 30Sep2024 instead of 30Apr2025.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96244
Status: Active
Manufacturer: Becton Dickinson & Co.
Sold By: Laboratory suppliers; Medical distributors
Manufactured In: United States
Units Affected: 247 units
Distributed To: Arizona, California, Colorado, Georgia, Kentucky, Illinois, Indiana, North Carolina, New Jersey, New York, Massachusetts, Maryland, Texas, Washington

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.