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U.S. Department of Health and Human Services

Class 2 Device Recall Kaluza C Software

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  Class 2 Device Recall Kaluza C Software see related information
Date Initiated by Firm June 23, 2021
Create Date August 11, 2021
Recall Status1 Open3, Classified
Recall Number Z-2241-2021
Recall Event ID 88247
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2
Kits:
C10574 - Kaluza C Single Perpetual License
C10575 - Kaluza C Single User 1-year License
C10576 - Kaluza C 10 User Network License
C10577 - Kaluza C 5 User Network License
C10578 - Kaluza C Single Perpetual Educational License
C10579 - Kaluza C Single User 1-year Educational License
C10580 - Kaluza C 10 User Network Educational License
C10581 - Kaluza C 5 User Network Educational License and
C21166 - Kaluza C Program DVD v1.0
Code Information Versions: 1.0, 1.1.1 and 1.1.2
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information Contact Customer Support Center
800-369-0333
Manufacturer Reason
for Recall		 Software anomalies that may lead to the generation of erroneous results.
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm notified its consignees via mail and email on 06/28/2021. Customers were provided with actions to take via customer letter. New customers will be affected by the issue. A stuffer letter will be implemented in new product to notify new customers. New customers downloading Kaluza software from the website will be notified of the issue via email during the downloading process. Product Disposition: A Stop Ship was placed on Kaluza software in order to implement the letter in new kits.
Quantity in Commerce 1,085 (482 US & 603 OUS)
Distribution Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MS, NC, NE, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, and Hawaii. The countries of Australia, Austria, Bahrain, Belgium, Bolivia, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Israel, Italy, Kenya, Korea, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Reunion, Saudi Arabia, Slovakia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Tunisia, U.A.E, Ukraine, United Kingdom, and Vietnam.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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