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

Recall Insight

This FDA Devices action (record #Z-1637-2024) was formally reported on May 1, 2024, with the manufacturer initiating the action on March 5, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Quidel Corporation is listed as the recalling firm, operating out of San Diego, CA. Federal records indicate 31,140 units units are affected.

The documented reason for this recall is: 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 no… Distribution data in the federal record shows the product reached: 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 K…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.