Agency classClass IIOur severity:Low FDA (Devices)·Z-2205-2017·Announced 2017-06-07

Cell Marque Recalls Herpes Simplex Virus I Reagents Due to Labeling Error

Cell Marque is recalling Herpes Simplex Virus I 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 error (missing 'For Export Only' label) with no reported health hazards or injuries, fitting the 'Low' severity criteria for packaging/documentation issues.

Plain-English summary

Cell Marque Corporation is recalling three units of Herpes Simplex Virus I reagents (Catalog number 361A-18). The affected products are 7.0 mL in vitro diagnostic reagents intended for microbiology use.

The recall was initiated because the products were intended to be sold outside the United States but were not properly labeled as "For Export Only," as required by section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act. The affected lots are 1432301A (expiry 2017-10) and 1525206A (expiry 2018-08).

The products 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 these specific lots and contact Cell Marque Corporation for further instructions.

The recalled product

Product: Herpes Simplex Virus I; 7.0 mL Catalog number 361A-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: 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 (4)

7.0 ml lot 1432301A
expiry 2017-10
lot 1525206A
expiry 201 8-08.

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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Same hazard · mis labeling