Summary
The FDA issued a Class II for QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests by Quidel Corporation. Reason: 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. I.
Details
Source
Device Recall
External ID
Z-1637-2024
Action Date
2024-05-01
Status
Ongoing
Category
device
Product Description
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests
Lot/Code Info: UDI: 30014613336747/Lot # 162620 and 162748
Quantity Affected: 31,140 units
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-05
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Quidel Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Quidel Corporation have FDA actions?
Quidel Corporation has 14 FDA actions in our database, including 8 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1637-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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