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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter Access Insulin

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  Class 2 Device Recall Beckman Coulter Access Insulin see related information
Date Initiated by Firm November 21, 2023
Date Posted February 05, 2024
Recall Status1 Open3, Classified
Recall Number Z-0981-2024
Recall Event ID 93724
510(K)Number K953084  
Product Classification Radioimmunoassay, immunoreactive insulin - Product Code CFP
Product Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Code Information UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388
Recalling Firm/
Manufacturer		 Beckman Coulter, Inc.
1000 Lake Hazeltine Dr
Chaska MN 55318-1037
For Additional Information Contact Rachel Davison
714-933-5321
Manufacturer Reason
for Recall		 There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an incorrect conversion factor when converting from system default units of ¿IU/mL to the International System of Units (SI units) of pmol/L.
FDA Determined
Cause 2		 Software design
Action Beckman Coulter issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/21/2023 via US mail and email. The notices explained the issues with the devices, the impact on test results, and requested the following actions be taken: Issue 1 - Configure the Access Ultrasensitive Insulin assay to the system default units (¿IU/mL). Refer to the appropriate system manuals for instructions. To manually convert concentrations to SI units (pmol/L), multiply ¿IU/mL by a multiplication factor of 7.0. Issue 2 - If the DxI 9000 Access Immunoassay Analyzer is connected to a host system, you can configure the host system to convert results from the system default units to the desired reporting units. If the DxI 9000 analyzer is not connected to a host system, revert all Access assays to their system default units to be sure the analyzer accurately reports dilution assay test results. Perform a retrospective review of all dilution assay test results that were reported in units other than the system default units. Issue 3 - Discontinue using the calculated result feature on the DxI 9000 user interface. Calculations can be performed manually or at the host system. For assay results that have already been run, if a calculated result of 0 was obtained, perform a retrospective review to ensure none of the assay results contained a > or < result. If any of the assay results contained a > or < then the calculated result interpretation should be corrected to no result . Issue 4 - If a reserve volume order is not run automatically as identified by a sample event notification, reload the sample to complete the ordered test. Alternatively, to ensure reserve volume is aliquoted, on the Menu > System Configuration > Test Menu screen, reenter the assay LIS code to match the assay Test ID shown on screen. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have
Quantity in Commerce 19,125 reagent packs
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Croatia, Czech Republic, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CFP and Original Applicant = BIO-RAD LABORATORIES, INC.
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