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Recall Observatory FDA recall evidence

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

Z-0799-2014

December 20, 2013

Class II

Product summary

Firm
Zeiss, Carl Inc
Event
Event 67178
Status
Terminated
Classification
Class II
Quantity
335 units Total (14 domestically & 321 internationally)
Official record key
device-enforcement:Z-0799-2014

Official wording

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 information: part number 473704-0000-000

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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