Z-1637-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 1, 2024
- Initiation Date
- March 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,140 units
Product Description
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
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.
Distribution Pattern
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
Code Information
UDI: 30014613336747/Lot # 162620 and 162748