Diamedix Is-Mumps IgG Test Kit Recalled for Gel-Like Contaminant
Diamedix Corporation is recalling 505 units of the Is-Mumps IgG Enzyme Immunoassay Test Kit because a gel-like contaminant may affect product performance.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor performance issues.
Plain-English summary
Diamedix Corporation is recalling 505 units of the Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use, Catalog No. 720-540. The recall involves Lot S0406 with an expiration date of 05/31/2018.
The recall was initiated because the product contains a gel-like contaminant that may affect product performance. This is a Class III recall, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected units were distributed in Arizona, California, Florida, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas, and Wisconsin. Users should stop using the product and contact Diamedix Corporation for further instructions.
The recalled product
- Product
- Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540
- Manufacturer
- Diamedix Corporation
- Affected units
- 505
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 (1)
- Lot S0406 Exp. 05/31/2018
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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