Z-1636-2024Class II

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

Name: Z-1636-2024 QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Creator: Quidel Corporation
Published: 2024-03-05
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-03-05 / Open, Classified / root cause: manufacturing process

FDA source

Quidel Corporation began a recall of QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests on 2024-03-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1636-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-05
Posted: 2024-04-24
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Product code: PFQ Mmp-9 Test System
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.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On March 5, 2024, QuidelOrtho issued a correction notification to affected consignees. QuidelOrtho asked consignees to take the following actions: 1. Please complete and return the attached confirmation of notification form to QuidelOrtho via fax at 858.203.9297 or email at [email protected]. 2. Indicate the amount of product to be replaced on the confirmation of notification form. You are not required to take any action related to already used kit material. 3. If requesting replacement product, discontinue use, render unusable, and discard the remaining inventory of affected lot numbers once replacement product arrives. 4. If unaffected replacement product is not immediately available or you wish to continue testing, please follow these steps, as applicable, to minimize patient risk: 4a. Immediately prior to running a test, carefully inspect each unused InflammaDry test device to ensure two faint orange lines appear in the result window prior to use. Only open and inspect the test device immediately prior to use as the device should not be stored outside of the foil pouch. 4b. Do not use any of the InflammaDry test devices if two faint orange lines are not visible prior to use. Please request replacement for any unused devices using the confirmation of notification form. . 4c. Perform external controls with each new lot, each new shipment, and every 30 days, per the package insert recommendations. Ensure the positive control produces expected results. 5. To report adverse events, contact your local Technical Solutions Center. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088.
Quantity in commerce: 104,300 units
Distribution: 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
Product codes and lots: UDI: 30014613336754/Lot # 162621 162695 162498 162718 162749 163025

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1636-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1636-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24
Z-1637-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-24

Product code PFQ

K132066Class IInflamma DryRapid Pathogen Screening, Inc. / cleared 2013-11-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)