FDA recall Z-1636-2024

Product

QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 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.

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

Key facts

Status

Ongoing

Initiation date

2024-03-05

Report date

2024-05-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2024