Diamedix Recalls Is-anti-Sm Test Kits Due to Control Failure
Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.
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, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
Diamedix Corporation is recalling 65 units of the Is-anti-Sm Test Kit, Catalog No. 720-240, Lot # T0401. The recall was initiated because the positive control recovered high out of specification.
The affected test kits were distributed worldwide, including nationwide in the United States and in Italy, Chile, and Ecuador. The Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease.
Users should stop using the affected test kits and contact Diamedix Corporation for further instructions.
The recalled product
- Product
- The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results…
- Manufacturer
- Diamedix Corporation
- Hazard
- Affected units
- 65
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)
- Catalog # 720-240
- Lot # T0401
- Expiration Date: November 18. 2012
Distribution
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