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U.S. Department of Health and Human Services

Class 2 Device Recall Ringed DxI Reaction Vessels (RVs)

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 Class 2 Device Recall Ringed DxI Reaction Vessels (RVs)see related information
Date Initiated by FirmJune 20, 2023
Date PostedJuly 26, 2023
Recall Status1 Open3, Classified
Recall NumberZ-2237-2023
Recall Event ID 92576
510(K)NumberK023764 
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductRinged DxI Reaction Vessels (RVs)
Code Information UDI: 15099590229979; Catalog Number: 386167; Lot Numbers: L17855111, L17798598, L18046334
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information Contact
952-448-4848
Manufacturer 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 Determined
Cause 2		Under Investigation by firm
ActionA 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 Commerce213 cases of 10,000 RVs (2,130,000 RVs)
DistributionWorldwide - US Nationwide distribution in the states of CA, MA, TX, NJ, MI, GA, NC, FL, WV and the country of Qatar.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = JJE
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