Recall Z-1636-2024— Quidel Corporation

Name: FDA recall Z-1636-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-05

Class II · Ongoing

Class II FDA medical device recall by Quidel Corporation, initiated 2024-03-05. It names one FDA 510(k) clearance: K132066. Product: QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests. Reason: 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..

Recalling firm: Quidel Corporation
Classification: Class II
Status: Ongoing
Initiated: 2024-03-05
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K132066 — INFLAMMA DRYRapid Pathogen Screening, Inc.·cleared 2013-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.