QUIDEL InflammaDry MMP-9 Test — Class II medical device recall Z-1636-2024
Ongoing recall by Quidel Corporation, reported 2024-05-01, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. There are two windows on the test device, the control line window and the test results window. The line for th
| Recall number | Z-1636-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Quidel Corporation, San Diego, CA, United States |
| Recall initiated | 2024-03-05 |
| Classified | 2024-04-24 |
| Reported by FDA | 2024-05-01 |
| Distributed | 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 |
| Countries outside the US | AE, BE, CA, CL, CN, DE, ES, GB, IE, IT, KR, LT, QA |
| Quantity | 104,300 units |
| UPC / GTIN / UDI-DI | 30014613336754 |
| Lot numbers | 162498, 162621, 162695, 162718, 162749, 163025 |
| Model numbers | PRS-ID-20-U |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1636-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.