Sysmex CA-600 series with built-in barcode reader. An in vitro diagnostic medical device (IVD) 의 리콜

Recall

RC-2017-RN-00807-1

Class II

2017-06-22

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00807-1

Siemens healthcare has been advised by sysmex corporation about a phenomenon affecting the specific sysmex ca-600 series systems. under rare circumstances there is the potential that the system might fail to alert the operator about an individual sample id number assigned to multiple patient measurement results when using the built-in barcode scanner. this may lead to an incorrect diagnostic and patient treatment decision due to potential of a mismatched result for the patient.

Sysmex is advising that: 1. In case an error message "Barcode Scanner Driver Error" appears during a CA-600 series sampler run with built-in barcode scanner, a blockage has stopped the barcode scanner from normal operation. The scanner cannot move from home position to #1, #2, ..#10 (all) sample tube position at the sampler rack, then back to home position. 2. Remove any block or failure. 3. Before clearing the error, confirm on the instrument display if the same sample IDs exist on the measurement results. The number of samples loaded should match the number of sample ID# displayed, & should correspond to the barcoded sample IDs for each of the samples loaded in the rack. 4. If you find anything wrong on the measurement results for the patient sample ID, reset the sample ID according to the note described in "5.11 Set Sample Nos." section of IFU. 5. Do not report previous patient results & restart analysis, verify results & sample ID No. for all specimens in the rack.