# FDA recall Z-1636-2024

> **Quidel Corporation** · Class II · device recall initiated 2024-03-05.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-1636-2024
- **Recalling firm:** Quidel Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-05
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1636-2024

## Citation

> AI Analytics. FDA recall Z-1636-2024. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1636-2024. Source: US FDA. Licensed CC0.

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