FDA-Device2024-05-01Class II
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Quidel Corporation
Hazard
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.
Sold states
US: AK AL AR AZ CA CO CT DC FL GA HI IA ID IL IN KS KY LA MA MD MI MN MO MT NC ND NE NH NJ NV NY OH OK OR PA SC SD TN TX UT VA WA WI WV OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar
Affected count
104,300 units
Manufactured in
10165 McKellar Ct, N/A, San Diego, CA, United States
Products
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief