Medical diagnostic test kits recalled due to misaligned results window
Quidel InflammaDry MMP-9 test kits are recalled because the test results window is misaligned. Positive results may be hidden from view, potentially causing false negative readings.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 of a diagnostic medical device with a functional defect that can cause false negative results. Although no illnesses or injuries have been reported, the defect represents a significant risk-of-harm scenario where diagnostic accuracy is compromised.
Plain-English summary
Quidel Corporation is recalling 31,140 units of the InflammaDry MMP-9 Test (REF: PRS-ID-20, Lot 162620 and 162748) due to a manufacturing defect.
The test device has a control line window and a test results window. The test results window line is misaligned, which can hide positive test results under the cassette, resulting in false negative readings where positive results go undetected.
This product was distributed nationwide across the United States and internationally to Canada, United Kingdom, China, South Korea, Belgium, Chile, Germany, Spain, Ireland, Italy, Lithuania, Qatar, and the United Arab Emirates.
The recalled product
- Product
- QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- Manufacturer
- Quidel Corporation
- Category
- Medical Device — Diagnostic Test
- Affected units
- 31,140
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: 30014613336747/Lot # 162620 and 162748
Distribution
Part of a larger recall action
This product is one of 2 recalled by Quidel Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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