FDAClass IIMay 1, 2024

QUIDEL InflammaDry MMP-9 Test recall

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 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: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025

Product
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Recalling firm
Quidel Corporation
Quantity
104,300 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)
Open FDA enforcement record Latest recalls