Reported Jun 20, 2018 · Terminated

Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning…

Zeiss, Carl Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zeiss, Carl Inc · 1 Zeiss Dr · Thornwood, NY · 10594-1939

Is this the product you have?

  • Cell Observer SD, DirectFRAP, Laser TIRF 1, Laser TIRF 2, Laser TIRF3, LightSheet, Elyra, and multiple Laser Scanning Microscopes. Laser scanning microscopes are used in cell biology research.
Lot codes and dates
  • Model No. Cell Observer SD, Laser TIRF, and DirectFRAP Laser Scanning Microscopes
Amount recalled
1070 units to US

Where it was sold

  • Nationwide

Why it was recalled

In certain eyepiece configurations the laser shutter may not close completely, permitting reflected beams that may be greater than the Class I limit.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 21, 2020 · Data as of Sep 19, 5:28 PM UTC

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