Reported May 1, 2024 · Ongoing
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Quidel Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Quidel Corporation · 10165 McKellar Ct · San Diego, CA · 92121-4201
Is this the product you have?
- QUIDEL InflammaDry MMP-9 Test
- REF
PRS-ID-20-U20 Tests
- Lot codes and dates
- UDI30014613336754/Lot # 162621 162695 162498 162718 162749 163025
- Amount recalled
- 104,300 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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