Device product
UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System, Software Version 3.2. The DxH Slidemaker Stainer allows for adaptation of the smear appearance and stain methodology according to user preferences. Blood smears produced by the Slidemaker portion of the DxH Slidemaker Stainer are moved to baskets for transfer to the Stainer portion by a robot arm. Microscopic examination of the stained blood smears can be used to help determine the hematologic status of a patient. A stained blood film: Allows for the differentiation of white blood cells, facilitates the characterization of red blood cells and platelets, and aids in the identification of blood components and cellular abnormalities.
Z-3101-2017
Product summary
- Event
- Event 77778
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310 units
- Official record key
device-enforcement:Z-3101-2017
Official wording
Reason: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.
Code information: P/N A85371AA20; Catalog No. 775222
Distribution pattern: Worldwide Distribution - USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV., and to the countries of : Australia, Brazil, Canada, Chile, China, Czech Republic, Denmark, France, Greece, Hong Kong, India, Israel, Italy, Japan, Morocco, Portugal, South Korea, South Africa, Spain, Taiwan, Turkey, United Kingdom, Vietnam, and Switzerland.
Derived failure modes
-
Unknown
The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.