Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C1
Summary
The FDA issued a Class II for Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 by Beckman Coulter, Inc.. Reason: Software anomalies that may lead to the generation of erroneous results..
Details
Source
Device Recall
External ID
Z-2241-2021
Action Date
2021-08-18
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Versions: 1.0, 1.1.1 and 1.1.2
Quantity Affected: 1,085 (482 US & 603 OUS)
Reason for Recall
Software anomalies that may lead to the generation of erroneous results.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-06-23
Company
Miami, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2241-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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