Cell Marque Recalls Estrogen Reagent Due to Missing Export Labeling
Cell Marque is recalling specific lots of Estrogen Receptor reagents because they were not labeled 'For Export Only' as required by law.
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 driven by a documentation and labeling error (missing 'For Export Only' text) rather than a product defect or safety hazard, which aligns with the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
Cell Marque Corporation is recalling specific lots of Estrogen Receptor (EP1) reagents. The affected products include 7.0 mL vials (Catalog number 249R-28, Lot 1326605C, expiry 2018-06) and 1.0 mL vials (Catalog number 249R-16, Lot 14035068, expiry 2017-01). These are in vitro diagnostic reagents intended for microbiology use.
The recall was initiated because the products were intended to be sold outside the United States but were not properly labeled as "For Export Only." This labeling omission violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.
The products were distributed nationwide to facilities in California, Colorado, Delaware, Florida, Georgia, Illinois, Kentucky, Maryland, Massachusetts, Mississippi, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, and Texas. Users should check their inventory for these specific catalog numbers and lot numbers. If found, the products should be removed from use and returned to the manufacturer or disposed of according to local regulations, as they are not approved for domestic sale.
The recalled product
- Product
- Estrogen Receptor (EP1) 7.0 mL Catalog number 249R-28; 1.0 mL Catalog number 249R-16 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
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 (4)
- 7.0 ml lot 1326605C
- expiry 2018-06
- 1.0 ml lot 14035068
- expiry 2017-01.
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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