Zeiss Microscope Polarizer D Component Recalled for Misaligned Plate
Carl Zeiss Microscopy is recalling Polarizer D components for upright Zeiss microscopes due to a misaligned full-wave plate.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a misaligned optical component which may affect diagnostic accuracy but does not present an immediate physical safety risk such as injury or death, fitting the criteria for a moderate severity voluntary recall.
Plain-English summary
Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in upright ZEISS microscopes, including the Axio Imager, Axio Scope.A1, and Axio Lab.A1 models. The recall is due to a misaligned full-wave (lambda) plate in the component.
The affected units were distributed in the states of Michigan, Texas, South Dakota, Florida, Georgia, and New York. The specific model number for the recalled component is 445226-0000-000.
Users of these microscopes should contact Carl Zeiss Microscopy for instructions on how to resolve the issue with the misaligned plate.
The recalled product
- Product
- Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
- Manufacturer
- Zeiss, Carl Inc
- Hazard
- Affected units
- 10
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)
- Model # 445226-0000-000
Distribution
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