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Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Official notice

12 Aug 2026

Last checked

22 Sept 2026

LowFDA

An official FDA notice concerns Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL. The notice reports a health risk requiring medical assessment. Stop using the product and follow the official notice. Published 2026-08-12. Recall numbers: Z-2880-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

8

Recall number

Z-2880-2026

Official notice

2026-08-12

The hazard

Health risk requiring medical assessment

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Other

UDI-DI 00842768001406

Event Ids

99379

Recall Numbers

Z-2880-2026

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Affected products

Product 1

Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL

Units affected

8

Risk / hazard

Health risk requiring medical assessment

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

US · United States

Affected area 1

US · United States

Affected area 2

JP · Japan

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens Healthcare Diagnostics. Contact: Siemens Healthcare Diagnostics, Inc..

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class III

App estimate

low

Recall details

Recall number

Z-2880-2026

Event id

99379

Units affected

8

Status

active

Classification

Class III

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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