QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Reported: May 1, 2024 Initiated: March 5, 2024 #Z-1637-2024
Product Description
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 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.
Details
- Recalling Firm
- Quidel Corporation
- Units Affected
- 31,140 units
- Distribution
- US: 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 OUS: United Arab Emirates, Belgium, Canada, Chile, China, Germany, Spain, United Kingdom, Ireland, Italy, South Korea, Lithuania, Qatar
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests. Recalled by Quidel Corporation. Units affected: 31,140 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1637-2024.
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