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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94499

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
April 18, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Beckman Coulter, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

DxI 9000 Access Immunoassay Analyzer, C11137; in-vitro diagnostic

Z-2264-2024
Recall number
Z-2264-2024
Initiated
April 18, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Beckman Coulter, Inc.
Quantity
116 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Beckman Coulter is recalling their DxI 9000 Access Immunoassay Analyzers, an in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids, by correction. The reason for the recall is: Beckman Coulter has determined that the DxI 9000 Access Immunoassay analyzer accepts calibrator values scanned from multiple calibrator cards when an operator configures a new calibrator lot. The analyzer accepts the calibrator lot values from any scanned calibrator card, regardless of the assay test code or calibrator material lot number. The software is not validating the integrity of each calibrator barcode scanned to ensure they are all from the same calibrator card. This includes all software versions and all DxI 9000 instruments that are currently in the field. This issue does not impact calibrator material with 2D calibrator card barcodes. This may cause a failed calibration curve. The health risk to patients is dependent upon the analytes that could be impacted by the error, to include receiving delayed or erroneous results. The issue was identified by Beckman Coulter while conducting a field action on DxI 9000 Access Immunoassay Analyzers.

Code information

UDI/DI 15099590230623, Serial Numbers: 300116, 300117, 300123, 300124, 300126, 300128, 300129, 300130, 300131, 300133, 300134, 300135, 300136, 300137, 300138, 300139, 300141, 300142, 300143, 300145, 300146, 300147, 300148, 300149, 300150, 300151, 300152, 300153, 300154, 300155, 300156, 300157, 300158, 300160, 300161, 300162, 300163, 300164, 300166, 300167, 300168, 300169, 300170, 300171, 300172, 300174, 300176, 300178, 300179, 300180, 300181, 300182, 300183, 300188, 300189, 300190, 300191, 300192, 300193, 300194, 300195, 300196, 300197, 300198, 300199, 300200, 300201, 300202, 300203, 300204, 300205, 300206, 300207, 300208, 300209, 300210, 300211, 300212, 300213, 300214, 300215, 300216, 300217, 300218, 300219, 300220, 300221, 300222, 300223, 300224, 300226, 300227, 300228, 300229, 300230, 300231, 300232, 300233, 300234, 300235, 300236, 300237, 300238, 300239, 300240, 300241, 300242, 300243, 300244, 300245, 300246, 300247, 300248, 300249, 300251, 300252, 300253, 300254, 300255, 300256, 300257, 300258, 300259, 300260, 300261, 300263, 300264, 300266, 300269, 300270, 300271, 300272, 300273, 300274, 300275, 300276, 300277, 300279, 300280, 300281, 300282, 300283, 300284, 300285, 300286, 300287, 300288, 300289, 300290, 300291, 300292, 300293, 300294, 300295, 300297, 300298, 300299, 300300, 300301, 300302, 300303, 300304, 300305, and 300306

Distribution pattern

Worldwide distribution.