Quidel InflammaDry MMP-9 Test: Misaligned Results Window May Cause False Negatives
Quidel Corporation is recalling 104,300 units of InflammaDry MMP-9 diagnostic tests due to misalignment of the test results window. Positive results may be hidden and not visible, potentially leading to false negative readings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a diagnostic test with a theoretical risk of patient harm through false negative results. No illnesses, injuries, or hospitalizations have been reported. Per the rubric, this represents a risk-of-harm product where injury has not yet been reported, warranting a High severity.
Plain-English summary
Quidel Corporation is recalling 104,300 units of its InflammaDry MMP-9 Test (REF: PRS-ID-20-U) due to a manufacturing defect affecting the test device. The test results window is misaligned on certain units, which may cause positive test results to be hidden under the cassette of the test device.
When a positive result is not visible, patients and healthcare providers may incorrectly read the test as negative. This could result in missed diagnoses and delayed or foregone treatment for patients who actually have the condition being tested for.
The affected units were distributed nationwide across all U.S. states and internationally to the United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, and Qatar. The recall affects lot numbers 162621, 162695, 162498, 162718, 162749, and 163025.
Healthcare providers and patients should stop using the affected units immediately and contact Quidel Corporation for replacement units or additional information.
The recalled product
- Product
- QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
- Manufacturer
- Quidel Corporation
- Category
- Medical Device — Diagnostic Test
- Hazard
- false-negative
- misalignment
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025
Distribution
Distributed in 44 states:
- 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
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