Z-0981-2024Class II

Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410

Name: Z-0981-2024 Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Creator: Beckman Coulter, Inc.
Published: 2023-11-21
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2023-11-21 / Open, Classified / root cause: software

FDA source

Beckman Coulter, Inc. began a recall of Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410 on 2023-11-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0981-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-21
Posted: 2024-02-05
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
Product code: CFP Radioimmunoassay, Immunoreactive Insulin
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.
Root cause tag: software
FDA root cause: 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.
Product codes and lots: UDI/DI 15099590230623, Lot Numbers: 125533, 125589, 233656, 233919, 234055, 234339, 234388

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0981-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0981-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-05
Z-0982-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-14	2024-02-05

Product code CFP

K953084Class IAccess Ultrasensitive Insulin AssayBio-Rad Laboratories, Inc. / cleared 1995-09-25

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)