Recall Z-1744-2013
Zeiss, Carl Inc · initiated May 28, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Polarizer D Fixed w/Rotating Red 1 lambda plate. Utilized in upright Zeiss microscopes to aid in diagnosis by means of color variation.
Codes / lots: Model # 445226-0000-000
Reason for recall
Carl Zeiss Microscopy, LLC is recalling the Polarizer D component used in All upright ZEISS microscopes (Axio Imager, Axio Scope.A1, Axio Lab.A1) due to Misaligned Full-Wave (Lambda) Plate.
FDA-determined cause: Nonconforming Material/Component
Action taken
On May 28, 2013, Carl Zeiss Microscopy, LLC recalled a Polarizer Component due to Misaligned Full-Wave (Lambda) Plate. Carl Ziess Microscopy distributed notices to their customers via e-mail. Carl Zeiss Microscopy, LLC requests that all customers immediately discontinue the use of the component for any applications which rely on accurate color-change sequence results. Your service provider will contact you to schedule a visit in which a factory trained service technician will confirm the alignment of your Polarizer D component;s lambda plate. If it is defective, a new Polarizer D component will be installed. There will be no charge for this action. Should you have any questions related to this issue, please do not hesitate to the Carl Zeiss facility in New York by telephone 914-681-7815 or via email at ed.mancini@zeiss.com
Details
- Recall number
- Z-1744-2013
- Initiated
- May 28, 2013
- Posted by FDA
- July 17, 2013
- Terminated
- October 29, 2014
- Product code
- IBJ – Light, Microscope
- Quantity
- 10
- Distribution
- Distributed in the states of MI, TX, SD, FL, GA, NY, and NY.
- Recalling firm
- Zeiss, Carl Inc, Thornwood, NY