Agency classClass IIOur severity:Low FDA (Devices)·Z-2206-2017·Announced 2017-06-07

Cell Marque Recalls Herpes Simplex Virus II Reagents for Labeling Errors

Cell Marque is recalling specific lots of Herpes Simplex Virus II reagents because they were not properly labeled as 'For Export Only' as required by federal law.

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 classified as Low severity because it involves a documentation and labeling issue (missing 'For Export Only' text) with no reported health hazards, injuries, or illnesses.

Plain-English summary

Cell Marque Corporation is recalling two specific lots of Herpes Simplex Virus II Analyte Specific Reagents intended for in vitro diagnostic use. The affected products are the 0.5 ml version (catalog number 362A-15, lot 1512811A) and the 7.0 mL version (catalog number 362A-18, lot 1512810E), both with an expiry date of April 2018.

The recall was initiated because the company identified that the products were intended to be sold outside the United States but were not properly labeled as "For Export Only." This labeling failure violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic 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 check their inventory for these specific lot numbers and stop using the products if found.

The recalled product

Product: Herpes Simplex Virus II 0.5 ml catalog number 362A-15 7.0 mL Catalog number362A-18 . Microbiology - Analyte Specific Reagent In vitro diagnostic use - Analyte Specific Reagent
Manufacturer: Cell Marque Corporation
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
Affected units: 2

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)

0.5 ml lot 1512811A
Expiry 201 8-04
7.0 ml lot 1512810E
expiry 2018-04.

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

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Same hazard · mis labeling