Recall Z-0799-2014— Zeiss, Carl Inc
Class II · Terminated
Class II FDA medical device recall by Zeiss, Carl Inc, initiated 2013-12-20, terminated 2015-04-08. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Zeiss, Carl Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-20
- Terminated
- 2015-04-08
- Firm location
- Thornwood, NY, United States
Product 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 for recall
Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate.
Data sourced from openFDA. This site is unofficial and independent of the FDA.