Recall Z-2691-2024— Beckman Coulter Mishima K.K.
Class II · Ongoing
Class II FDA medical device recall by Beckman Coulter Mishima K.K., initiated 2024-07-10. It names one FDA 510(k) clearance: K220977. Product: DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.. Reason: Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results..
- Recalling firm
- Beckman Coulter Mishima K.K.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-10
- Firm location
- Sunto-Gun, Japan
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.
Reason for recall
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will be reported. This issue may cause a delay of results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.