FDAMay 5, 2017device
Her2/Neu (EP3); 0.5 mL Catalog number 237R-25; 1.0 mL Catalog number 237R-26; 7.0 mL Catalog number 237R-28. Immunology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
cell marquecell
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-162021-07-15
- FDACell Marque, RabMAb,CD17, c-kit (YR145) Rabbit Monoclonal Primary Antibody, REF: 117R-18, IVD, CE, GTIN: 008416831237982021-05-27
- FDACell Marque Antibodies, MSH6 (44), Mouse Monoclonal Antibody, REF: 287M-10, IVD, CE, GTIN: 008416831045132021-05-27
- CPSCEndliss Technology Recalls Trianium Battery Phone Cases Due to Burn Hazard; Sold Exclusively on Amazon.com2020-10-07
- FDACherrybrook Kitchen***Gluten Free***Wheat Free***SUGAR COOKIE MIX***NET WT. 13 OZ2020-05-16
- FDAHodgson Mill Unbleached All-Purpose White Wheat Flour 5 Lb bags 001042 Best By 10-01-2020 005517 Best By 10-02-20202019-11-27
- FDAHer2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent2017-05-05
- FDAAdenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent2017-05-05
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