Recall Z-1636-2024

Reason for recall

There are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned. In instances of positive test results, the positivite test line may not be visible/ hidden under the cassette of the test device thus potentially leading to a false negative result.

FDA-determined cause: Process design

Action taken

On March 5, 2024, QuidelOrtho issued a correction notification to affected consignees. QuidelOrtho asked consignees to take the following actions: 1. Please complete and return the attached confirmation of notification form to QuidelOrtho via fax at 858.203.9297 or email at customernotifications@quidelortho.com. 2. Indicate the amount of product to be replaced on the confirmation of notification form. You are not required to take any action related to already used kit material. 3. If requesting replacement product, discontinue use, render unusable, and discard the remaining inventory of affected lot numbers once replacement product arrives. 4. If unaffected replacement product is not immediately available or you wish to continue testing, please follow these steps, as applicable, to minimize patient risk: 4a. Immediately prior to running a test, carefully inspect each unused InflammaDry test device to ensure two faint orange lines appear in the result window prior to use. Only open and inspect the test device immediately prior to use as the device should not be stored outside of the foil pouch. 4b. Do not use any of the InflammaDry test devices if two faint orange lines are not visible prior to use. Please request replacement for any unused devices using the confirmation of notification form. . 4c. Perform external controls with each new lot, each new shipment, and every 30 days, per the package insert recommendations. Ensure the positive control produces expected results. 5. To report adverse events, contact your local Technical Solutions Center. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088.