Diamedix IgG Test Kits Recalled Due to Sample Diluent Contamination
Diamedix Corporation is recalling 588 EBV-VCA and Mumps IgG test kits because a gel-like substance in the sample diluent could compromise performance.
What this means for you
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, but the source text describes a potential performance compromise due to a gel-like substance without reporting any specific injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Diamedix Corporation is recalling 588 units of the Diamedix Is-EBV-VCA IgG Test Kit and Diamedix Is-Mumps IgG Test Kit. These kits are enzyme immunoassay (EIA) procedures intended for the qualitative and semi-quantitative detection of IgG antibodies to aid in the diagnosis of Mumps and EBV 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 units are identified by Lot # 30804, Catalog # 720-600, and have an expiration date of April 30, 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 of these test kits should stop using the affected lots and contact Diamedix Corporation for further instructions.
The recalled product
- Product
- Diamedix Is-EBV-VCA 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
- Affected units
- 588
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 # 30804
- Catalog # 720-600 Expiration Date April 30
- 2015
Distribution
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 →Related recalls
Same manufacturer · Diamedix Corporation
See all →- LowDiamedix EBV Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08
- LowDiamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant
FDA (Devices) · 2018-08-08
- ModerateDiamedix IgG Test Kits Recalled Due to Gel-Like Substance in Diluent
FDA (Devices) · 2016-05-25
- ModerateDiamedix Is-Mumps IgG Test Kit Recalled Due to Sample Diluent Contamination
FDA (Devices) · 2016-05-25
- ModerateDiamedix Is-CMV IgG Test Kit Recalled for Incorrect Substrate
FDA (Devices) · 2016-05-25