Beckman Coulter, Inc. Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Brand
Beckman Coulter, Inc.
Lot Codes / Batch Numbers
UDI-DI: 15099590230623, U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. OUS serial numbers have been requested.
Products Sold
UDI-DI: 15099590230623; U.S. serial numbers: 300284, 300286, 300294, 300266, 300291, 300223, 300260, 300285, 300292, 300195, 300227, 300228, 300205, 300207, 300206, 300182, 300192, and 300234. OUS serial numbers have been requested.
Beckman Coulter, Inc. is recalling Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device use due to When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
When the DxI 9000 Access Immunoassay Analyzer with system software version 1.16.2 and prior is configured to automatically request a calibration order, the instrument can process the order with expired calibrator material. If the calibration curve is generated with an expired calibration material lot, this may lead to a hazardous situation of erroneously high or low patient results reported to the physicians.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 4/12/2024 on 4/18/2024 via first class mail. The letter described the issue, the impact, and actions to be taken, which included: (a) Verify the calibrator material expiration date before ordering a calibration on the analyzer; (b) Cancel calibration orders after the calibrator lot material expires. Instructions for canceling a calibration order are provided in the device help system or in the Calibration section of the IFU; (c) Repeat any test results generated from a calibration curve that used expired calibrator lot material. The resolution provided was that the firm is investigating the root cause of the issue and will implement the correction with a future software release. A service representative will contact the consignee to schedule the software upgrade when it is available. The letter is to be shared with laboratory staff and retained as part of the laboratory Quality System documentation. If the device has been forwarded to another laboratory, the consignee is to provide a copy of the letter to that laboratory. A Response Form was enclosed for completion and return within 10 days to assure the information has been received.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IN, KS, NH, NJ, OK, PA, TX
Page updated: Jan 10, 2026