Z-1636-2024 Class II Ongoing
FDA device recall Z-1636-2024 was initiated by Quidel Corporation on March 5, 2024 and is designated Class II. 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 positivi… The recall status is ongoing. Affected quantity: 104,300 units.
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
- 104,300 units
Product Description
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 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: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025