FDA Enforcement Class II Terminated

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 pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.

Recall: Z-0799-2014 · Reported January 29, 2014

Enforcement

Recall Number
Z-0799-2014
Event ID
67178
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Zeiss, Carl Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
January 29, 2014
Initiation Date
December 20, 2013
Classification Date
January 21, 2014
Termination Date
April 8, 2015
Address
1 Zeiss Dr, Thornwood, NY, 10594-1939, United States

Description

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 pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research.

Reason

Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.

Code Info

part number 473704-0000-000

Distribution

Worldwide Distribution - Nationwide including NY, TX, NC, FL, ME, MA and MI; and Internationally to Arab Emirates, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Egypt, France, Germany, Hong Kong, India, Italy, Kosovo, Lithuania, Mexico, The Netherlands, New Zealand, Peru, Poland, Spain, and Taiwan.

Quantity

335 units Total (14 domestically & 321 internationally)