The Recall Desk
ModerateFDA (Devices)·Z-0799-2014·Announced 2014-01-29

Zeiss Compensator Slider Lambda 6x20 Recalled for Misalignment

Carl Zeiss Microscopy is recalling the Compensator Slider Lambda 6x20 component due to misalignment of the lambda plate.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a mechanical misalignment with no reported injuries or illnesses, fitting the criteria for a moderate severity recall involving a defect without immediate harm reports.

Plain-English summary

Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lambda 6x20 component (part number 473704-0000-000). This component is utilized on Standard Pathology Microscopes and is used to determine the composition of urinary calculi, urinary sediments, bio-crystallates, and the diagnosis of pathological characteristics in medical applications, such as testing for gout or pseudogout. It is also used for non-medical scientific research.

The recall was initiated due to misalignment of the lambda plate within the component. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.

A total of 335 units are affected, with 14 distributed domestically in the United States and 321 distributed internationally. Domestic distribution includes New York, Texas, North Carolina, Florida, Maine, Massachusetts, and Michigan. International distribution covers numerous countries including Canada, Germany, France, and China. Users of these microscopes should contact the manufacturer for further instructions.

The recalled product

Product
Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathol
Manufacturer
Zeiss, Carl Inc

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • part number 473704-0000-000

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically: