Home / Recalls / Medical Devices
Quidel Corporation recalls QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Recalled May 1, 2024 · FDA recall Z-1637-2024 · Quidel
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. · FDA Class II
Units
31,140 units
Sold at
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
Description
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.
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Manufacturer(s)
Quidel Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →