Quidel recalls 20-test InflammaDry MMP-9 Test (REF PRS-ID-20-U) due to misaligned test line causing false negatives in positive results. Affected units have specific UDI and lot numbers.
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.
Quidel is recalling its InflammaDry MMP-9 Test kits because the test line can be hidden under the cassette, leading to false negative results when the test is positive. This means users might think they don't have the condition when they actually do.
The test results window line is misaligned with the control line. In positive tests, this line can be hidden under the cassette, causing the test to show negative when it should be positive. This leads to false negatives where the condition is present but not detected.
People who own or use the QUIDEL InflammaDry MMP-9 Test kits with the specified UDI and lot numbers are affected. Those testing for MMP-9 levels in blood samples are most at risk of missing a positive result.
Check the product label for the UDI: 30014613336754 and lot numbers 162621 through 163025. The test kit is labeled as QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests.
Look for the UDI code 30014613336754 and lot numbers 162621 to 163025 on the test kit.
The test results window line is misaligned, which can cause false negative results in positive tests by hiding the line under the cassette.
The recall record does not specify a remedy, so no action is required beyond checking if your kit has the affected UDI and lot numbers.
Check the product label for UDI: 30014613336754 and lot numbers 162621 through 163025.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1636-2024 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1636-2024 from Quidel. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
