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Beckman Coulter Mishima K.K. FDA Recalls
6 recalls on file across devices, 0 of them Class I and 4 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| DxC 700 AU, REF: B86444, B86446Class IIJan 30, 2026A delay in results may occur. When clinical chemistry analyz |
| CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281Class IIJan 30, 2026A delay in results may occur. When clinical chemistry analyz |
| Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot Class IIApr 30, 2025A manufacturing defect in the sample probe (S probe). The co |
| Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot Class IIApr 30, 2025Sample probes with defective probe tips, when used with clin |
| DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samplClass IIJul 10, 2024Due to a software issues, after the instrument processes 250 |
| DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samplClass IIJun 5, 2024There are two software bug issues with the analyzer. Issue 1 |