Ringed DxI Reaction Vessels (RVs)
FDA device recall Z-2237-2023 · posted 2023-07-26 · Open, Classified
Recall details
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- JJE
- Quantity affected
- 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.
- Date initiated
- 2023-06-20
- Date posted
- 2023-07-26
- Location
- Chaska, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 (K023764) | Beckman Coulter, Inc. | 2003-01-28 |