Z-2237-2023Class II

Ringed DxI Reaction Vessels (RVs)

Name: Z-2237-2023 Ringed DxI Reaction Vessels (RVs)
Creator: Beckman Coulter, Inc.
Published: 2023-06-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-06-20 / Open, Classified

FDA source

Beckman Coulter, Inc. began a recall of Ringed DxI Reaction Vessels (RVs) on 2023-06-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2237-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-06-20
Posted: 2023-07-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Ringed DxI Reaction Vessels (RVs)
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: 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.
FDA 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 in commerce: 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.
Product codes and lots: UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2237-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2237-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-02	2023-07-26

Product code JJE

K023764Class IUnicel Dxi 800 Access Immunoassay System, Model 973100Beckman Coulter, Inc. / cleared 2003-01-28

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)