MicroVue C1-Inhibitor Plus EIA kits recalled for potential test failure
Quidel is recalling specific lots of MicroVue C1-Inhibitor Plus EIA test kits that may produce low optical density values and invalid test results.
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard is a manufacturing defect in the microtiter plates causing test failure and invalid results—a functional issue rather than a direct patient safety threat.
Plain-English summary
Quidel Corporation is recalling MicroVue C1-Inhibitor Plus EIA test kits used to measure functional C1-Inhibitor protein levels in human plasma and serum samples.
The affected kits contain microtiter plates that may produce low optical density (OD) values, preventing the test from meeting validation requirements. This causes the test run to fail and produce invalid results.
Healthcare providers and laboratories using the affected lot (213783, Catalog Number A037, REF 4634, with ID 2200 or above) should discontinue use and contact Quidel Corporation for replacement or further guidance.
The recalled product
- Product
- MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein in human plasma or serum, Catalog Number A037, Containing Coated Strips, REF: 4634, with an ID number of 2200 or above
- Manufacturer
- Quidel Corporation
- Hazard
- Affected units
- 771
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 (2)
- UDI: 30014613335580
- Lot Number: 213783
Distribution
Distribution scope not specified by the agency.
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