Reported Jul 24, 2019 · Terminated
Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc. for the following software devices: (A)…
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Kaluza C Flow Cytometry Software, RX Only in the U.S.A., Beckman Coulter, Inc
- for the following software devices(A) Kaluza C Perpetual License (B) Kaluza C Single Use 1 Year License (C) Kaluza C 5 User Network (D) Kaluza C 10 User Network (E) Kaluza C Perpetual Educational License (F) Kaluza C Single User 1 Year educational License (G) Kaluza C 10 User Network Educational License (H) Kaluza C 5 User Network Educational License (I) Kaluza C Flow Cytometry Software
- Lot codes and dates
- A
- C10574/UDI15099590705084 B
- C10575/UDI15099590705091 C
- C10576/UDI15099590705114 D
- C10577/UDI15099590705107 E
- C10578/UDI15099590705121 F
- C10579/UDI15099590705138 G
- C10580/UDI15099590705145 H
- C10581/UDI15099590705152 I
- C21166/UDI15099590705169
- Amount recalled
- 41 units
Where it was sold
Why it was recalled
Compatibility issue between the software and Microsoft updates to Windows 7, 8, and 10. The compatibility issue causes the software to be unusable which could result in a delay of reporting results.
This product could cause temporary or reversible health problems — stop using it.
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