🔍 RecallPedia

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

Class I - Dangerous
🏥 Medical Devices Recalled: November 21, 2023 Beckman Coulter Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI/DI 15099590732103, Serial Numbers: 300116, 300117, 300118, 300123, 300127, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300138, 300139, 300137, 300140, 300142, 300141, 300144, 300143, 300145, 300148 300146, 300147, 300149, 300150, 300151, 300152, 300155, 300153, 300154, 300156, 300158, 300160, 300163, 300161, 300162, 300164, 300167, 300170, 300169, 300171, 300168, 300166, 300172, 300176, 300173, 300178, 300181, 300179, 300183, 300182, 300188, 300189, 300190, 300191, 300192, 300195, 300196, 300193, 300194, 300197, 300199, 300198, 300201, 300200, 300202, 300203, 300205, 300204 300207, 300206, 300208, 300209, 300212, 300210, 300211, 300213, 300214, 300215, 300217, 300216, 300220, 300218, 300219, 300221, 300223, 300224, 300222, 300227, 300228, 300229, 300231, 300230, 300235, 300236, 300234, 300237, 300232, 300239, 300233, 300238, 300240, 300243, 300241, 300242, 300247, 300246, 300249, 300253, 300244, 300250, 300252, 300248, 300251, 300256, 300257, 300254, 300258, 300255, 300259, 300260, 300261, 300264, 300263, 300262; running software version 1.16 or prior
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Beckman Coulter, Inc.
Reason for Recall:
There are potential performance issues found in the DxI 9000 Access Immunoassay Analyzer, including: 1) Access Ultrasensitive Insulin users who configure SI units (pmol/L) applies an incorrect conversion factor; 2) System provides numerical results that are below the lowest reportable result if laboratory chooses to report assay results in units of measurement other than the defined default units; 3) A result of 0 incorrectly reported when the system utilizes an expression that utilizes non-numerical symbols (e.g., > or <) to derive a calculated test as part of result reporting; 4) Reserve volume is enabled and the assay LIS code is not the same as the assay Test ID. These issues could potentially lead to erroneous results or delay reporting results for multiple analytes.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,

Product Codes/Lot Numbers:

UDI/DI 15099590732103, Serial Numbers: 300116, 300117, 300118, 300123, 300127, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300138, 300139, 300137, 300140, 300142, 300141, 300144, 300143, 300145, 300148 300146, 300147, 300149, 300150, 300151, 300152, 300155, 300153, 300154, 300156, 300158, 300160, 300163, 300161, 300162, 300164, 300167, 300170, 300169, 300171, 300168, 300166, 300172, 300176, 300173, 300178, 300181, 300179, 300183, 300182, 300188, 300189, 300190, 300191, 300192, 300195, 300196, 300193, 300194, 300197, 300199, 300198, 300201, 300200, 300202, 300203, 300205, 300204 300207, 300206, 300208, 300209, 300212, 300210, 300211, 300213, 300214, 300215, 300217, 300216, 300220, 300218, 300219, 300221, 300223, 300224, 300222, 300227, 300228, 300229, 300231, 300230, 300235, 300236, 300234, 300237, 300232, 300239, 300233, 300238, 300240, 300243, 300241, 300242, 300247, 300246, 300249, 300253, 300244, 300250, 300252, 300248, 300251, 300256, 300257, 300254, 300258, 300255, 300259, 300260, 300261, 300264, 300263, 300262; running software version 1.16 or prior

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0982-2024

Related Recalls

Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

Beckman Coulter

Class I - Dangerous

It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.

Nov 7, 2025 Infusion Pumps Nationwide View Details →

DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light scatter detection channels. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument.

Beckman Coulter

Class I - Dangerous

Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.

Sep 22, 2025 Diagnostic Equipment Nationwide View Details →