Quidel recalls 20-test InflammaDry MMP-9 Test (lot #162620/162748) due to misaligned test line causing false negatives in positive results. Consumers should check UDI for affected units.
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 may be hidden under the cassette, leading to false negative results in positive tests. This could cause incorrect health conclusions if the test is used without noticing the result.
The test results window line is misaligned, so in positive tests, the positive line might be hidden under the cassette. This could cause the test to show negative when it's actually positive, leading to missed health issues.
Users of the QUIDEL InflammaDry MMP-9 Test kits with UDI 30014613336747 and lot numbers 162620 or 162748 are affected. Those who have used the test recently for medical purposes may be at higher risk of incorrect results.
Check the product's Unique Device Identifier (UDI) on the packaging: 30014613336747. Also look for lot numbers 162620 or 162748 on the label.
Verify the Unique Device Identifier (UDI) and lot numbers on the packaging to confirm if your test kit is affected.
The recalled product is QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20, 20 Tests with UDI 30014613336747 and lot numbers 162620 or 162748.
The test results window line is misaligned, which can cause the positive line to be hidden under the cassette, potentially leading to false negative results in positive tests.
Check the product's Unique Device Identifier (UDI) and lot numbers to confirm if it's affected. If it is, you may want to contact Quidel for further instructions.
We’ve drafted a message you can send Quidel to request your refund or repair — edit it as you like.
Subject: Recall Z-1637-2024 — Quidel Quidel Hello, I own a Quidel that is covered by recall Z-1637-2024 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.
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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.
