Cell Marque Recalls HHV-8 Reagent Due to Export Labeling Error
Cell Marque is recalling HHV-8 in vitro diagnostic 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 due to a documentation and labeling error (missing 'For Export Only' label) with no reported health hazards, injuries, or product defects, fitting the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
Cell Marque Corporation is recalling 11 units of HHV-8 (13810) in vitro diagnostic reagents. The affected products include 1.0 ml vials (catalog number 265M-16, lot 1626403D) and 7.0 ml vials (catalog number 265M-18, lot 1625207H), both with an expiration date of August 2019.
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," as required by section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act. This is a labeling compliance issue rather than a product safety or efficacy defect.
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. Consumers and healthcare facilities should stop using these specific lots and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- HHV-8 (13810); 1.0 ml catalog number 265M-16; 7.0 ml catalog number-265M-18; Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 11
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 (3)
- 1.0 ml lot 1626403D
- expiry 2019-08
- 7.0 mL lot. 1625207H
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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