Home / Recalls / Beckman Coulter Inc. / Z-3101-2017

Z-3101-2017 Class II Terminated

Recalled by Beckman Coulter Inc. — Brea, CA

FDA device recall Z-3101-2017 was initiated by Beckman Coulter Inc. on June 20, 2017 and is designated Class II. Reason for recall: The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation. The recall status is terminated (terminated April 21, 2021). Affected quantity: 310 units.

Recall Details

Product Type
Devices
Report Date
September 6, 2017
Initiation Date
June 20, 2017
Termination Date
April 21, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
310 units

Product Description

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.

Reason for Recall

The firm has identified that a fitting in some Slidemaker Stainer units may not completely seal after installation.

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.

Code Information

P/N A85371AA20; Catalog No. 775222

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FDA data resources