Official recall record
Ringed DxI Reaction Vessels (RVs)
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-06-20
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 15099590229979
- Brand on record
- Beckman Coulter, Inc.
What the authority reported
Beckman Coulter, Inc. is recalling Ringed DxI Reaction Vessels (RVs) as part of Unicel DxI Immunoassay System (600, 800 series). The reason for the recall is that the firm has identified 3 lots of RVs that failed an internally used service test to evaluate washing efficiency. Increased relative light units (RLU) suspected to be caused by the resulting rough interior surface may lead to artificially falsely elevated results for susceptible tests, in particular, sandwich assays including, but not limited to, hsTnI, Hybritech p2PSA, IPTH/IPTH IO.
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 2026-05-31.
Other recalls from this brand
- 2026-09-21 · US FDA — Medical Devices
ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima X - 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
All 39 official recall notices naming Beckman Coulter, Inc. on this site →