—#208114

Product

Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete photometric chemistry analyzer for clinical use. It is an in-vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids with Catalog Number C11137.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: UDI/DI 15099590732103, Serial Numbers: 300273, 300275, 300276, 300277, 300281, 300282, 300284, 300286, 300297

Why it was recalled

The reason for the recall is the pneumatic tubing used in the analytical pick-and-place (PnP) assembly cable may fully or partially disconnect from the flex cable assembly fittings during normal operation. The DxI 9000 Access Immunoassay Analyzer may generate a System Event log message that indicates PnP errors. Any cancelled tests will have an associated SYS flag. The analyzer may enter the Red-system status because of this issue. The analyzer also may not eject RVs, where unbound conjugate could potentially splash up on the sidewall of the RV, not being properly washed away, resulting in an artificially higher signal (RLU). The analyzer may not detect this splashing and continue with normal operation, which can cause false low or high erroneous results. Consequently, the analyzer may cancel in-progress tests. These errors could potentially cause delay reporting patient test results and patient treatments. The degree of the potential health hazard is dependent on the analytes that are potentially delayed, especially those analytes that would be used in the acute setting when treatment decisions are immediate. In this particular recall the highest risk analyte is troponin. Health consequences could include permanent impairment or possibly death if medical treatment decisions are delayed due to a delay in obtaining patient results. The issue was identified by Beckman Coulter Inc. manufacturing staff at their location in Brea California on February 29, 2024, during in-process acceptance inspection activities.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Beckman Coulter issued an Urgent Medical Device Recall notice to its consignees on 05/299/2024 via mail and email. The notice explained the problem with the device, impact to patient and user, and requested the following actions: . Repeat testing should be at the discretion of the laboratory's medical director. . Your Beckman Coulter service representative will contact you to schedule a part replacement for this issue. Contact your Beckman Coulter representative if your laboratory has experienced any PnP errors. For questions regarding this notice, please contact our Customer Support Center: http://www.beckmancoulter.com.

Recalling firm

Firm: Beckman Coulter, Inc.
Address: 1000 Lake Hazeltine Dr, Chaska, Minnesota 55318-1037

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the state of Indiana and the countries of Italy, Sweden, Ireland, Spain.

Timeline

Recall initiated: 2024-02-29
Posted by FDA: 2024-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208114. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.