Recall Z-1636-2024 ยท PFQ Mmp-9 Test System
Quidel Corporation
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
| Date | Apr 24, 2024 (initiated Mar 5, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process design |
| Action | On March 5, 2024, QuidelOrtho issued a correction notification to affected consignees. QuidelOrtho asked consignees to take the following actions: 1. Please complete and return the attached confirmation of notification form to QuidelOrtho via fax at 858.203.9297 or email at customernotifications@quidelortho.com. 2. Indicate the amount of product to be replaced on the confirmation of notification form. You are not required to take any action related to already used kit material. 3. If requesting replacement product, discontinue use, render unusable, and discard the remaining inventory of affec |
| Quantity | 104,300 units |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132066 | INFLAMMA DRY Rapid Pathogen Screening, Inc., Nov 21, 2013 |