🔍 RecallPedia

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Class I - Dangerous
🏥 Medical Devices Recalled: May 5, 2017 Cell Marque Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    1.0 ml lot 16175038, expiry 2019-05; 7.0 mL lot 1617502A, expiry 2019-05; lot 16175020, expiry 2019-05 and lot 1511403J, expiry 2018-03.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cell Marque Corporation
Reason for Recall:
Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent

Product Codes/Lot Numbers:

1.0 ml lot 16175038, expiry 2019-05; 7.0 mL lot 1617502A, expiry 2019-05; lot 16175020, expiry 2019-05 and lot 1511403J, expiry 2018-03.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2209-2017

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Cell Marque

Class I - Dangerous

Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.

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