FDAFDA · Food and drugs·Recall number Z-2204-2017
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
Published June 7, 2017 · Recall initiated: May 5, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cell Marque Corporation
- Distributor
- Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
- Lot
- 0.5 ml lot 1418111A , expiry 2017-05; 1.0 ml lot, 1619706E , expiry 2019-06; 7.0 ml lot 1418112A, expiry 2017-05; lot 14181, expiry 12G 2017-05.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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