Cell Marque Recalls Varicella Zoster Virus Reagent Due to Labeling Error
Cell Marque is recalling Varicella Zoster Virus 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 compliance issue (missing 'For Export Only' label) with no reported health hazards or product defects, fitting the 'Low' severity criteria for packaging/documentation problems.
Plain-English summary
Cell Marque Corporation is recalling one lot of Varicella Zoster Virus 7.0 ml reagents (catalog number 364M-18, lot 15261038, expiry 2018-08). The product is an in vitro diagnostic reagent intended for microbiology use.
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" 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 defect.
The affected product was 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 should stop using the affected lot and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- Varicella Zoster Virus 7.0 ml catalog number 364M-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 1
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 15261038
- Expiry 2018-08
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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