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GEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 00077415008 00077415010 00077430010 Product Description: The

Official notice

12 Aug 2026

Last checked

22 Sept 2026

MediumFDA

An official FDA notice concerns Instrumentation Laboratory. 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-2899-2026. Check the official notice for the complete list.

What to do now

Instructions for consumers are available in the official FDA notice.

Units affected

32

Recall number

Z-2899-2026

Official notice

2026-05-21

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 00195226000764, UDI-DI 00195226000665, UDI-DI 00195226000856, UDI-DI 00195226000757, UDI-DI 00195226000658, UDI-DI 00195226000641

Event Ids

99128

Recall Numbers

Z-2899-2026

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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

CN · China

Affected area 3

DE · Germany

Affected area 4

IT · Italy

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Instrumentation Laboratory. Contact: Instrumentation Laboratory.

Source & status

Source

Tier

official

Category

ELECTRONICS

Classification

Class II

App estimate

medium

Recall details

Recall number

Z-2899-2026

Event id

99128

Units affected

32

Status

active

Classification

Class II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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