Agency classClass IIOur severity:Low FDA (Devices)·Z-2199-2017·Announced 2017-06-07

Cell Marque Recalls Adenovirus Reagents Due to Export Labeling Error

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

Plain-English summary

Cell Marque Corporation is recalling specific lots of Adenovirus (20/11 & 2/6) Analyte Specific Reagents. The affected products include the 0.5 mL size (Catalog # 212M-15) and the 7.0 mL size (Catalog # 212M-18). These are in vitro diagnostic reagents intended for microbiology use.

The recall was initiated because the company identified that the product, which was intended to be sold outside the United States, was not properly labeled as "For Export Only." This labeling failure violates section 801(e)(1) of the Federal Food, Drug, and Cosmetic Act.

The recall involves 12 units 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. Affected lots include 0.5 mL units with lot number 1318203P and expiry date 2018-04, and 7.0 mL units with lot numbers 1318204H 201 (expiry 8-04 11) and 1532111A (expiry 2018-10). Users should stop using these specific lots and contact Cell Marque for instructions.

The recalled product

Product: Adenovirus (20/11 & 2/6); 0.5 mL Catalog # 212M-15; and 7.0 mL Catalog number 212M-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: 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 (5)

0.5 mL - 1318203P
Expiry 2018-04
7.0 mL - 1318204H 201
Expiry 8-04 11 and 1532111A
expiry 2018-10.

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