The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2209-2017·Announced 2017-06-07

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Category
Medical Device — In Vitro Diagnostic Reagents
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

Distributed nationwide across the United States.

The notice also names 18 states specifically:

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 →

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