Cell Marque Recalls Her2/Neu Reagents for Missing Export Labeling
Cell Marque is recalling Her2/Neu (EP3) reagents because they were not properly labeled as 'For Export Only' as required by the FD&C Act.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and labeling issue (missing 'For Export Only' label) with no reported injuries, illnesses, or product defects, fitting the criteria for a Low severity recall.
Plain-English summary
Cell Marque Corporation is recalling specific lots of Her2/Neu (EP3) reagents intended for in vitro diagnostic use. The recall was initiated after the company identified that the product was not properly labeled as "For Export Only," which is required by section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.
The affected products include 0.5 mL, 1.0 mL, and 7.0 mL vials with catalog numbers 237R-25, 237R-26, and 237R-28, respectively. The recall covers 10 units distributed nationwide to laboratories in California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, and Texas.
Healthcare facilities and laboratories that have received these specific lots should stop using the product and contact Cell Marque Corporation for instructions on return or disposal. This recall addresses a regulatory labeling deficiency rather than a product safety defect or contamination issue.
The recalled product
- Product
- 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
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 10
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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.
Distribution
Part of a larger recall action
This product is one of 12 recalled by Cell Marque Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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