InflammaDry RPS-ID-20Recalls & reported problems

Quidel Corporation · InflammaDry · Class 1

All models of InflammaDry (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K132066); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

Mar 5, 2024Class IIOpen, Classified
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.
Z-1637-2024 · Root cause: Process design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132066. One submission often covers many models, so check the product and lot details in each record.

Z-1636-2024 · Mar 5, 2024 · Open, Classified
QUIDEL InflammaDry MMP-9 Test, REF: PRS-ID-20-U, 20 Tests
Z-2803-2017 · Jun 22, 2017 · Terminated
InflammaDry(R) AN RPS DIAGNOSTIC SOLUTION, Sample Collectors InflammaDry(R) is a rapid, immunoassay test for the visual, qualitative, in vitro detection of elevated levels of the M

Device details

UDI-DI	`30014613336747`
Brand	InflammaDry
Model	RPS-ID-20
Company	Quidel Corporation
Product code	PFQ · MMP-9 test system
Class	Class 1
FDA submission	K132066
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jun 16, 2023

Device type (GMDN): Matrix metalloproteinase-9 (MMP-9) IVD, kit, rapid ICT, clinical

A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of matrix metalloproteinase-9 (MMP-9) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses to aid in the diagnosis of dry eye syndrome. It is not intended to be used for self-testing.

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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