Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
- Product distributed for use as an In-vitro Diagnostics without FDA clearance
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Cell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 00841683123798
Product Codes/Lot Numbers:
Lot Numbers: 0000058081/ Exp: 31 Dec 2021, 0000072580/ Exp: 30 Sep 2021, 0000090505/ Exp: 30 Sep 2022, 0000121052/ Exp: 31 May 2023
Distribution:
Distributed in: US, AL, AR, AZ, CA, FL, HI, ID, IL, KY, MN, MT, NC, NH, NY, PA, SC, VA, WI
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2105-2021
Related Recalls
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.
Cell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 00841683104513
Cell Marque
Product distributed for use as an In-vitro Diagnostics without FDA clearance
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.