Diagnostic Hybrids Recalls MicroVue CIC-C1q EIA Kits Due to Validation Concerns
Diagnostic Hybrids, Inc. is recalling 101 MicroVue CIC-C1q EIA kits because the standard curve slope may fail validation requirements.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific hazard is a potential failure to meet validation requirements, which is a quality control issue rather than a direct physical injury or contamination risk.
Plain-English summary
Diagnostic Hybrids, Inc. is recalling 101 units of the MicroVue CIC-C1q EIA, Model A001. This is an enzyme immunoassay used to detect circulating immune complexes in human serum or plasma. The specific lot number for the recalled product is 084007.
The recall was initiated because there is a potential for the slope of the standard curve to fail to meet the assay validation requirements. This issue could affect the accuracy of the test results.
The products were distributed to the US states of New York, Texas, Colorado, and Utah, as well as to Switzerland. Users of this product should contact Diagnostic Hybrids, Inc. for further instructions on how to proceed.
The recalled product
- Product
- MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of circulating immune complexes in human serum or plasma. The assay uses highly pure, functional human C1q coated in the solid phase to capture immune complexes (CIC). In the first stage, CIC in the dilut
- Manufacturer
- Diagnostic Hybrids, Inc.
- Hazard
- Affected units
- 101
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 084007
Distribution
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