Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1687-2016·Announced 2016-05-25

Diamedix IgG Test Kits Recalled Due to Gel-Like Substance in Diluent

Diamedix Corporation is recalling 94 Is-EBV-EA-D and Is-Mumps IgG Test Kits because a gel-like substance was found in the sample diluent, potentially compromising performance.

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. The hazard is a potential compromise in product performance due to a foreign substance, with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Diamedix Corporation is recalling 94 units of the Is-EBV-EA-D IgG Test Kit and the Is-Mumps IgG Test Kit. These are enzyme immunoassay (EIA) procedures intended for the qualitative and semi-quantitative detection of specific IgG antibodies to aid in the diagnosis of Mumps and Epstein-Barr Virus infections.

The recall was initiated because a gel-like substance was found in the kit component known as the sample diluent. This substance could potentially compromise the performance of the product. The affected products are identified by Lot # 51104, Catalog # 720-640, and have an expiration date of August 31, 2015.

The affected kits were distributed worldwide, including nationwide in the United States (specifically in AZ, CA, CO, FL, GA, IL, IN, KY, MA, MI, MO, NC, NE, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, and Puerto Rico) and in Italy. Users should stop using the affected kits and contact Diamedix Corporation for further instructions.

The recalled product

Product: Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.
Manufacturer: Diamedix Corporation
Category: Medical Device — In Vitro Diagnostics
Hazard: contamination
product-performance
Affected units: 94

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 (3)

Lot # 51104
Catalog # 720-640 Expiration Date August 31
2015

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Diamedix 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 3 products in this recall →

Same manufacturer · Diamedix Corporation

See all →

Low
Diamedix EBV Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08
Low
Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08
Moderate
Diamedix IgG Test Kits Recalled Due to Sample Diluent Contamination
FDA (Devices) · 2016-05-25
Moderate
Diamedix Is-Mumps IgG Test Kit Recalled Due to Sample Diluent Contamination
FDA (Devices) · 2016-05-25
Moderate
Diamedix Is-CMV IgG Test Kit Recalled for Incorrect Substrate
FDA (Devices) · 2016-05-25

Same hazard · contamination