Cell Marque Recalls CD117 Reagents Due to Missing Export Labeling
Cell Marque is recalling CD117, c-kit reagents because they were not labeled 'For Export Only' as required by the FD&C Act.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves minor labeling errors or low-risk issues that are unlikely to cause serious harm, fitting the 'Moderate' severity criteria.
Plain-English summary
Cell Marque Corporation is recalling 12 units of CD117, c-kit (YR145) reagents, including 1.0 ml and 7.0 ml vials. 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 FD&C Act.
The affected lots include 1.0 ml lot 16175038, 7.0 mL lot 1617502A, lot 16175020, and lot 1511403J, all with expiration dates in 2018 or 2019. The products 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.
This recall is a Class II recall, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. Consumers and laboratories should stop using the affected lots and contact Cell Marque for instructions on return or disposal.
The recalled product
- Product
- CD117, c-kit (YR145) 1.0 ml catalog number 117R-16 7.0 ml catalog number-18 Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
- Manufacturer
- Cell Marque Corporation
- Hazard
- Affected units
- 12
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 (7)
- 1.0 ml lot 16175038
- expiry 2019-05
- 7.0 mL lot 1617502A
- expiry 2019-05
- lot 16175020
- expiry 2019-05 and lot 1511403J
- expiry 2018-03.
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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