Cell Marque Recalls SV40 Reagent Due to Missing Export Labeling
Cell Marque is recalling three units of SV40 (MRQ-4) reagent 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 due to a documentation and labeling error (missing 'For Export Only' label) rather than a product defect or safety hazard, which aligns with the 'Low' severity criteria for documentation issues.
Plain-English summary
Cell Marque Corporation is recalling three units of SV40 (MRQ-4) 0.5 ml reagent, catalog number 351 M-15. The product is an in vitro diagnostic reagent intended for microbiology use. The specific lot affected is 1416002H, with an expiration date of May 2017.
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 failure to label the product correctly 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 instructions on return or disposal.
The recalled product
- Product
- SV40 (MRQ-4) 0.5 ml catalog number 351 M-15. Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 3
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)
- lot 1416002H
- expiry 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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