A customer from germany alleged a staining issue for one slide using the benchmark ultra instrument.One slide was intended for prepkit#185, however, an error message appeared requesting another antibody (cd34 (qbend10) for this slide.The issue was discovered as the requested antibody cd34 (qbend10) was not on the instrument.No results were generated.No harm is alleged.
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During the investigation, it was observed that the user deleted orders 15 times on (b)(6)2023.Once the order was deleted, the usid/barcode label was recycled.The issue was likely caused by another order created with the recycled usid/barcode label.A slide with a previously printed label was then loaded onto the instrument.The protocol, such as the human readable text, of the initially printed label does not match the protocol associated with the newly generated usid/barcode label.Thus a slide containing the initial label (if not discarded) could be stained with a protocol ordered for the new usid/barcode label.The issue will be addressed in the upcoming software update.There are several mitigating factors that allow the detectability of this scenario: the expected staining pattern of the intended assay, the use of the same slide and/or internal positive controls, comparison of the label to the run report which will show a protocol mismatch, and interpretation in conjunction with other relevant clinical information and assay results.----- date of event was updated to 2/7/2023.
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