Official recall record
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 a
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-09-21
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590416324
- Brand on record
- Beckman Coulter, Inc.
What the authority reported
Optima XE XPN ultracentrifuge rotors may contain a microstructure defect that can cause rotors to break into two or more pieces (bifurcate) during a centrifugation run, resulting in destruction of samples being processed. When used for in vitro diagnostic (IVD) sample preparation, rotor breakage may delay patient test results. Additionally, sample destruction may expose laboratory personnel to biohazardous materials.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-11-13.
Same barcode in other registries
The same EAN appears in 1 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.
- 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima XPN-100 (Mo
Other recalls from this brand
- 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW41, Reference Number 331362, when the rotors are installed in the following centrifuges: Optima X - 2026-08-12 · US FDA — Medical Devices
DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513 - 2026-08-12 · US FDA — Medical Devices
IQ200 SPRINT, REF: 700-3322,700-3322RFB, 700-3325, 700-3326, B48997; IQ200 SELECT, REF: 700-3340, 700-3345, 7
All 39 official recall notices naming Beckman Coulter, Inc. on this site →