FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Ringed DxI Reaction Vessels (RVs)
- Recall number
- Z-2237-2023
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Ringed DxI Reaction Vessels (RVs)
- Status
- Open, Classified
- Initiated
- 2023-06-20
- Posted
- 2023-07-26
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- A customer letter titled, Urgent Medical Device Recall, dated 06/07/2023, was issued to the impacted consignee via first-class mail and email. The consignee is instructed to discard the product and request a replacement. The consignee is asked to complete the response form and submit to the recalling firm.
- Quantity
- 213 cases of 10,000 RVs (2,130,000 RVs)
- Distribution
- Worldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.
- Lot, serial or model codes
- UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
- 510(k) numbers
- ["K023764"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28