QUIDEL InflammaDry MMP-9 Test recall
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Why was QUIDEL InflammaDry MMP-9 Test 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI: 30014613336747/Lot # 162620 and 162748
- Product
- QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
- Recalling firm
- Quidel Corporation
- Quantity
- 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
- Recall date
- May 1, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)