Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling
Cell Marque is recalling Her2/Neu (c-erbB-2) reagents because they were not labeled as 'For Export Only' as required by law.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 health hazard, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Cell Marque Corporation is recalling Her2/Neu (c-erbB-2) (CB-1 1) in vitro diagnostic reagents, catalog number 237M-18. The specific product affected is 7.0 mL, lot 11515602A, with an expiration date of May 2018.
The recall was initiated because the product was intended to be sold outside the United States but was not properly labeled as "For Export Only." This labeling omission violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.
The affected units were 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. Users of this product should stop using the affected lot and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - 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 (2)
- 7.0 ml lot 11515602A
- expiry 2018-05.
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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