Official recall record

DxC 500 AU Clinical Chemistry Analyzer (ref 77175)

What the authority reported

Beckman Coulter has determined that the DxC 500 AU Clinical Chemistry Analyzer might assign a test result to an incorrect sample ID under the following workflow conditions. After loading a barcoded sample tube (sample A) onto the DxC 500 AU Clinical Chemistry Analyzer, all tests ordered for that barcoded sample tube are locked into the specific position of that barcoded tube on the analyzer (for example, the position on the DxLab rack or position in the stat table) until all tests are completed or cancelled for that sample tube. A problem might occur if, for any reason, all tests ordered for that barcoded sample tube (sample A) are not completed or remain "in pending", and the operator attempts to analyze a second sample tube (sample B) in that same position on the rack or stat table. If the bar code for sample B is not successfully scanned by the analyzer or if the sample tube is not labelled, the analyzer assumes the sample that previously occupied that position has been reloaded (sample A). The analyzer will complete and report the pending tests associated with sample A, using sample B. No results will be reported for sample A. This issue does not arise if all barcoded sample tubes are successfully scanned or if testing is complete for the first barcoded sample (sample A). Recall Start Date: March 7, 2025

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

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