Quidel Corporation: Medical Device Recall in 2024 - (Recall #: Z-1636-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 5, 2024

Date Posted: May 1, 2024

Recall Number: Z-1636-2024

Event ID: 94219

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.

Status: Ongoing

Product Quantity: 104,300 units

Code Information:

UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated