Cell Marque Recalls H. pylori Reagent Due to Missing Export Labeling
Cell Marque is recalling five units of H. pylori reagent 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 issue (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 five units of H. pylori (polyclonal) 1.0 mL reagent, catalog number 215A-76. The product is an in vitro diagnostic reagent intended for hematology use. The specific lot affected is 1611307C, with an expiration date of 2019-03.
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 failure violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
The affected units 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 the product and contact Cell Marque Corporation for further instructions.
The recalled product
- Product
- H. pylori (polyclonal} 1.0 mL Catalog number 215A-76; Hematology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 5
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)
- 1.0 ml lot 1611307C
- expiry 201 9-03.
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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