Agency classClass IIOur severity:Low FDA (Devices)·Z-2208-2017·Announced 2017-06-07

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.

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 1/5 (Low).

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
Category: Medical Device — In Vitro Diagnostic Reagent
Hazard: mis-labeling
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

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 →

Same manufacturer · Cell Marque Corporation

See all →

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Moderate
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Cell Marque Recalls Her2/Neu Reagent Due to Missing Export Labeling
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Same hazard · mis labeling