Z-2241-2021Class II

Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual...

Name: Z-2241-2021 Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual...
Creator: Beckman Coulter, Inc.
Published: 2021-06-23
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-06-23 / Terminated / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of 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... on 2021-06-23. FDA classified it as Class II and gives the reason as "Software anomalies that may lead to the generation of erroneous results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-2241-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-23
Posted: 2021-08-11
Terminated: 2026-07-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: JQP Calculator/Data Processing Module, For Clinical Use
Reason for recall: Software anomalies that may lead to the generation of erroneous results.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: Versions: 1.0, 1.1.1 and 1.1.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2241-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2241-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-18	2021-08-11

Product code JQP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)