Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional Recalled by Quidel Corporation Due to Kits with affected microtiter plates have the potential...

Date: February 1, 2023
Company: Quidel Corporation
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Quidel Corporation directly.

Affected Products

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

Quantity: 771 units

Why Was This Recalled?

Kits with affected microtiter plates have the potential to produce low OD values, causing the run to fail, per the Validation requirements of the Package Insert.

Where Was This Sold?

not yet available

About Quidel Corporation

Quidel Corporation has 13 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report