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.
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. 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
- 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
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
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- LowDiamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant
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- ModerateDiamedix IgG Test Kits Recalled Due to Sample Diluent Contamination
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- ModerateDiamedix Is-Mumps IgG Test Kit Recalled Due to Sample Diluent Contamination
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- ModerateDiamedix Is-CMV IgG Test Kit Recalled for Incorrect Substrate
FDA (Devices) · 2016-05-25
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