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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 Softwaresee related information
Date Initiated by FirmJune 23, 2021
Create DateAugust 11, 2021
Recall Status1 Terminated 3 on July 02, 2026
Recall NumberZ-2241-2021
Recall Event ID 88247
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
ProductKaluza 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
FEI Number 3000203293
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
11800 Sw 147th Ave
Miami FL 33196-2500
For Additional Information ContactCustomer 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
ActionThe 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 Commerce1,085 (482 US & 603 OUS)
DistributionWorldwide 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 CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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