—#188213

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

FDA product code: JQP — Calculator/Data Processing Module, For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Versions: 1.0, 1.1.1 and 1.1.2

Why it was recalled

Software anomalies that may lead to the generation of erroneous results.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 11800 Sw 147th Ave, Miami, Florida 33196-2500

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-06-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188213. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.