FDAFDA · Food and drugs·Recall number Z-1636-2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Published May 1, 2024 · Recall initiated: March 5, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Quidel Corporation
- Distributor
- 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
- Lot
- UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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