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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

Copan Diagnostics Inc: 300uL Transfer Pipettes Recalled for Plastic Defects

Agency Publication Date: September 30, 2024
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Summary

Copan Diagnostics Inc. has recalled approximately 2,592 units of their 300uL Transfer Pipettes because of plastic defects that impact the tool's ability to pull up liquids correctly. These individually wrapped pipettes are used in medical and laboratory settings, and if they do not meet the expected suction tolerances, they could lead to inaccurate measurements during testing or sample transfers. Consumers should check their inventory for specific COPAN REF 2U045S01 products across 17 different lot codes and contact the manufacturer for further instructions.

Risk

The plastic defects interfere with the pipette's aspiration capability, meaning the device may not pull up the precise amount of liquid required for a procedure. This can lead to incorrect sample volumes being processed, potentially resulting in inaccurate diagnostic test results or experimental errors.

What You Should Do

  1. Identify the affected product by looking for COPAN REF: 2U045S01, specifically the '300uL Transfer Pipette' which is sold as individually wrapped pipettes in packs of 1,000.
  2. Check the packaging for UDI number 50841467100545 and any of the following lot codes: B104661, B202918, B203404, B203405, B204186, B204187, B204819, B204820, B300133, B300410, B300608, B300647, B300679, B301129, B301133, B301135, or B301134.
  3. Contact your healthcare provider or laboratory supervisor to determine if any tests performed using these specific pipettes need to be reviewed or repeated.
  4. Contact Copan Diagnostics Inc. at their Murrieta, California office for further instructions regarding the disposal or return of affected products.
  5. For additional questions or to report issues, contact the FDA's medical device recall line at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer and Healthcare consultation

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

Affected Products

Product: COPAN REF: 2U045S01 300uL Transfer Pipette (1000 pcs.)
Model / REF:
REF: 2U045S01
UPC Codes:
50841467100545
Lot Numbers:
B104661
B202918
B203404
B203405
B204186
B204187
B204819
B204820
B300133
B300410
B300608
B300647
B300679
B301129
B301133
B301135
B301134

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92832
Status: Active
Manufacturer: Copan Diagnostics Inc
Manufactured In: United States
Units Affected: 2,592 units
Distributed To: California

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.