FDA Device recall Z-1637-2024
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- FDA Device
- Class II
- ongoing
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests by Quidel, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1637-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-05 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Quidel |
| Distribution | 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 |
Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
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.
Identifiers
| code_info | UDI: 30014613336747/Lot # 162620 and 162748 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1637-2024%22
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